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A Study on Hair Dye Contact Dermatitis-Its Clinical Presentations and Allergens”

A Study on Hair Dye Contact Dermatitis-Its Clinical Presentations and Allergens”

“A STUDY ON CONTACT DERMATITIS-ITS CLINICAL PRESENTATIONS AND ALLERGENS”

Dissertation Submitted

In Partial fulfillment of the University regulations for

MD DEGREE IN DERMATOLOGY, VENEREOLOGY AND LEPROSY (BRANCH XX)

MADRAS MEDICAL COLLEGE

THE TAMILNADU DR. M.G.R. MEDICAL UNIVERSITY,

CHENNAI INDIA.

MAY 2019

CERTIFICATE

It is Certified that this dissertation titled “A STUDY ON HAIR DYE

CONTACT DERMATITIS-ITS CLINICAL PRESENTATIONS AND

ALLERGENS” is a bonafide work done by Dr. SUDHA K, Post graduate student of the Department of Dermatology, Venereology and Leprosy,

Madras Medical College, Chennai – 3, during the academic year 2016 –

2019. This work has not previously formed the basis for the award of any degree.

Prof. Dr. U.R. DHANALAKSHMI Prof. Dr. R. JAYANTHI., MD., D.D., D.N.B., M.D., F.R.C.P (Glasg) Professor and Head Dean Department of Dermatology Madras Medical College Madras Medical College & Chennai-3. Rajiv Gandhi Govt. General Hospital Chennai-3.

DECLARATION

The dissertation entitled “A STUDY ON HAIR DYE CONTACT

DERMATITIS-ITS CLINICAL PRESENTATIONS AND ALLERGENS” is a bonafide work done by Dr. SUDHA. K at Department of Dermatology,

Venereology and Leprosy, Madras Medical College, Chennai – 3, during the academic year 2016 – 2019 under the guidance of Prof. Dr. S. NIRMALA

M.D., Professor, Head of Department, Department of occupational and contact dermatitis, Madras Medical College, Chennai -3.

This dissertation is submitted to The Tamil Nadu Dr. M.G.R. Medical

University, Chennai towards partial fulfillment of the rules and regulations for the award of M.D Degree in Dermatology, Venereology and Leprosy

(BRANCH – XX)

Prof. Dr. S. NIRMALA, M.D, Professor and Head of Department Department of Occupational and Contact Dermatitis Madras Medical College Chennai-3.

DECLARATION

I, Dr. SUDHA.K solemnly declare that this dissertation titled

“A STUDY ON HAIR DYE CONTACT DERMATITIS-ITS CLINICAL

PRESENTATIONS AND ALLERGENS” is a bonafide work done by me at

Madras Medical College during 2016-2019 under the guidance and supervision of Prof. U. R. DHANALAKSHMI, M.D., D.D., D.N.B.,

Professor and Head of Department, Department of Dermatology, Madras

Medical College, Chennai-600003.

This dissertation is submitted to The Tamil Nadu Dr. M.G.R. Medical

University, Chennai towards partial fulfillment of the rules and regulations for the award of M.D Degree in Dermatology, Venereology and Leprology

(BRANCH – XX).

PLACE :

DATE : (DR. SUDHA K)

SPECIAL ACKNOWLEDGEMENT

My sincere thanks to Prof. Dr. R. JAYANTHI., M.D., F.R.C.P

(Glasg) Dean, Madras Medical College, Chennai-3 for allowing me to do this dissertation and utilize the Institutional facilities.

ACKNOWLEDGEMENT

I am grateful to the Professor and Head of the Department of Dermatology,

Prof. Dr. U.R. DHANALAKSHMI, M.D., D.D., D.N.B., for her advice, guidance and encouragement for my study.

I would like to express my sincere and heartfelt gratitude to

Prof. Dr. S. KALAIVANI, M.D., D.V., Director and Professor, Institute of

Venereology, for her kindness and support throughout the study.

I sincerely thank my guide Prof. Dr. S. NIRMALA M.D., Professor and

Head of Department, Department of Occupational and Contact Dermatitis for her valuable support. She has been a source of constant motivation and encouragement throughout the study. I am extremely grateful to her for guiding me throughout the study.

I sincerely thank Prof. Dr. R. PRIYAVATHANI ANNIE MALATHY, M.D.,

D.D., D.N.B., M.N.A.M.S., Professor of dermatology for her help and support.

I thank Prof. Dr. S. KUMARAVEL, M.D., D.D., Professor of Dermatology for his advice and encouragement.

I thank Prof. Dr. V. SAMPATH M.D., D.D., Professor of Dermatology for his advice and encouragement.

I thank Prof. Dr. A. RAMESH M.D., D.D., D.N.B., Professor of

Dermatology for his advice and encouragement.

I am grateful to Prof. Dr. J. MANJULA, M.D., D.N.B., Professor,

Department of Dermatology for her invaluable guidance, help and encouragement.

I thank Prof. Dr. AFTAB JAMEELA WAHAB, MD., D.D., Professor of

Dermatology for his advice and encouragement.

I wish to thank Dr. S. VIJAYA BASKAR, M.D., D.C.H., Additional professor, Institute of Venereology for his guidance.

I humbly thank my Co-Guide DR.K. DEEPA M.D.(DVL) Assistant professor, Department of Dermatology for her valuable guidance throughout my work. I would like to express my sincere and heartfelt gratitude for the time which they devoted for my research project.

I extend my gratitude to Dr.R. MADHU M.D, (DERM), D.C.H.,

Dr. SAMUEL JEYARAJ DANIEL M.D.D.V.L., Dr.V.N.S.AHAMED SHARIFF ,

M.D.D.V.L., Dr.B.VIJAYALAKHSMI M.D.D.V.L., Dr.K.UMAMAHESWARI,

M.D.D.V.L., Dr.R.MANIPRIYA, M.D.D.V.L., D.C.H and Dr.C.L.CHITRA,

M.D.DV.L., Dr. S.VENKATESAN, D.N.B., D.D Assistant professors, Department of Dermatology for their kind support and encouragement.

I also thank my Assistant Professors Dr. P. PRABHAKAR, M.D.D.V.L.,

Dr. C. VIDHYA, M.D.DVL., Dr.R.HEMAMALINI, M.D.D.V.L.,

Dr.H.DHANASELVI, M.D.D.V.L., Dr.K.GAYATHRI, M.D.D.V.L.,

Dr.E.BALASUBRAMANIAN, M.D.D.V.L and Dr.R.SNEKAVALLI M.D.D.V.L.,

Dr S.TAMILSELVI M.D.D.V.L, Dr T. VANATHI, M.D.D.V.L,

Dr. DURGAVATHY, M.D., D.D., Institute of Venereology for their able guidance.

I am thankful to my colleagues for their support throughout the study. I am also grateful to all paramedical staffs for rendering timely help to complete my study. Last but not the least I am profoundly grateful to all patients for their co- operation and participation in this study. They have been the principal source of knowledge which I have gained during the course of my clinical research.

CONTENTS

SL. PAGE TITLE NO. NO. 1. INTRODUCTION 1

2. REVIEW OF LITERATURE 3

3. AIMS & OBJECTIVES 28

4. MATERIALS AND METHODS 29

5. OBSERVATIONS & RESULTS 35

6. CLINICAL IMAGES

7. DISCUSSION 70

8. CONCLUSION 77

9. BIBLIOGRAPHY

10. ANNEXURES  ABBREVIATIONS  MASTER CHART  KEY FOR MASTER CHART  PROFORMA  INFORMATION SHEET

 CONSENT FORM  ETHICS COMMITTEE APPROVAL CERTIFICATE  PLAGIARISM SCREENSHOT  PLAGIARISM DIGITAL CERTIFICATE

Introduction

INTRODUCTION

Tremendous advancements in this cosmetic world have increased our ability to enhance youth and beauty. The desire for every individual to project a more youthful look, has led to the innovation of various hair coloring products.

Various commercially available hair can cause both irritant and allergic contact dermatitis. Allergic contact dermatitis is a delayed type of hypersensitivity reaction manifesting as pruritic dermatitis, which is elicited when the skin meets an allergen to which an individual has been previously sensitized (1). Allergic contact dermatitis (ACD) may clinically present with blisters, oozing, oedema

(acute), scaling(subacute), lichenification (chronic). Paraphenylenediamine

(PPD), the most common ingredient used in hair dye is the common cause of dermatitis (2). It may involve mainly the scalp and forehead.

This study was done to determine the various clinical presentations of allergic contact dermatitis (ACD) to hair dye and to confirm the common causative allergen of hair dye with the help of patch test. Hair is considered as an indicator of attractiveness, feminity, masculinity, health and beauty. Early identification of ACD to hair dye is of main concern because its adverse reactions affects the persons quality of life and confidence. It even forces the patient to change their occupation in case of hair dressers and cosmetic persons. Thus, early identification of hair dye dermatitis helps us in counselling the patient to avoid the causative hair dye product and change to an alternative natural hair dye or

1 hypoallergenic dye. A careful history and clinical examination help in identifying allergic contact dermatitis to hair dye. In India, very few studies have been conducted for the demographic profile and for the pattern of clinical presentations of hair dye dermatitis which is mandatory to know the burden of the disease.

Awareness about hair dye products and their effects ultimately helps in saving our health care resources and reducing the financial burden of the society.

Thus, this study was done to assess the demographic profile, most prevalent clinical presentations, common possible allergens in hair dye products in a tertiary care set up of our hospital in Chennai.

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Review of Literature

REVIEW OF LITERATURE

Dyes are colorants which are soluble in water and/or organic solvents, having a particle size of <0.01micrometer with affinity to colour substrates (3).

They have been widely used in industrial products, among which hair dyes are the frequently used . Hair dyes include a variety of ingredients known to cause allergic contact dermatitis like 2,7 naphthalene diol, 2-aminomethyl-p- aminophenol hydrochloride, 2- chloro-p-phenylenediamine, N-phenyl-p- phenylenediamine, O-aminophenol, p-aminophenol (4). Although many of these agents can cause allergic contact dermatitis, paraphenylenediamine (PPD) remains the most common agent for contact sensitivity (5). Due to its protein binding capacity, low molecular weight and ability to penetrate hair shafts, PPD is an effective constituent in hair dyes (5).

Apart from hair dyes PPD is also present in dyes for textiles, leather, fur, black rubbers and tattoos. As its structure contains 1,4 substituted benzenes, it cross reacts with para amino benzoic acid (PABA), sulphonamides, ester anaesthetics, para amino salicylic acid, thiazides, sesquiterpene-lactone mix and azo dyes (6). Even in low concentrations it is therefore, used as a best indicator and a useful patch test screening allergen for hair dye contact dermatitis (7).

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CLASSIFICATION OF HAIR DYES:

Based on their chemical composition, hair dyes can be broadly classified into 3 main categories

A) Vegetable hair dyes B) Metallic hair dyes C) Synthetic hair dyes - Direct hair dyes - Oxidative hair dyes

1. VEGETABLE DYES:

Henna is the only available vegetable hair dye. It is obtained from the dried leaves and stem of Lawsonia intermis. Natural henna gives a brownish orange color. Its active principle is Lawsone (2, hydroxy-1,4 naphthoquinone) (2). Black henna commercially available in recent times is a mixture of natural henna and

PPD is added to intensify the color and to decrease the frequency of application (2).

Natural henna has a low allergic potential. Most of the allergic reactions owing to henna are in fact because of the substances added to henna mixtures such as diaminotoluenes and diaminobenzenes (8). PPD is reported to be responsible for complications like localized or generalized contact dermatitis, hypertrophic or keloid scars and pigmentary changes after henna tattoos. 31 cases of ACD due to temporary henna tattoos were reported in Kazandijieva et al study (9). Allergic contact dermatitis to pure henna has also been reported but is extremely rare (10).

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2. METALLIC DYES:

Metallic dyes contain metals like lead acetate and salts of bismuth, silver, copper, nickel and cobalt. They give various range of colours. The disadvantage is that they tend to make hair brittle and are used rarely.

3. SYNTHETIC ORGANIC DYES:

They are of 2 types- direct and oxidative (11).

A) Direct hair dyes include - temporary and semi-permanent dyes.

B) Oxidative dyes include - permanent dyes.

BASED ON PERSISTENCE OF COLOR CLASSIFIED AS:

1. Temporary

2. Semi-permanent

3. Demi-permanent

4. Permanent

1. TEMPORARY – contains pigments which are of high molecular weight and

therefore cannot penetrate the cuticle layer.

2. SEMIPERMANENT – contains no or little developer (

and ), less damaging to hair strands, contains low molecular weight

pigments than temporary dyes, enters the hair shaft partially.

3. DEMIPERMANENT – contains alkaline agent other than ammonia (like

ethanolamine, sodium carbonate). Concentration of hydrogen peroxide in

developer is less than that in permanent dyes. Better than semipermeable dyes

in covering grey , but less than permanent dyes.

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4. PERMANENT – contains ammonia, mixed with a developer or oxidizing

agent. Duration of contact – 30- 45 mins.

CHEMICAL COMPOSITION OF PERMANENT HAIR DYE:

The process of hair coloring in permanent hair dye involves mixing of two components-

a) Precursor along with coupler

b) Oxidizing agent.

Precursors/primary intermediates:

Belong to aryl amine groups, includes para-phenylenediamine (PPD), para- toluene diamine (PTD), ortho-aminophenol, Para-aminophenol.

Coupler:

They are meta-substituted derivative of . Based on the colour they produce, they can be divided into,

1. blue coupler – 1,3 diaminobenzenes and its derivatives

2. red coupler – and naphthol’s

3. yellow-green couplers – resorcinol, 4-chloro resorcinol, and

benzodioxols(12).

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Formation of hair colour involves three steps:

STEPS:

 First step - Oxidation of p-phenylenediamine to the quinonimines

(C6H4(NH)2):

 Second step - Involves the attack of this quinonimines on the coupler. In

organic chemistry, this reaction is called electrophilic aromatic substitution:

 Third and final step - The product from the quinonimines-coupler reaction

oxidizes to the final hair dye.

The dye formed in the above reaction bonds to hair permanently. The main reason for a permanent colour on hair is by producing larger dye molecules, which is locked inside the hair.

ROLE OF AMMONIA IN HAIR DYE:

Ammonia is generally used in permanent hair dyes which must be mixed with a developer or an oxidizing agent to obtain the permanent change of colour.

It is an alkaline agent which opens up the cuticle layer and facilitates the penetration of both developer and colorants together into the cortex (13). Semi- permanent dyes contain ethanolamine and sodium carbonate for an alkaline pH.

ANATOMY OF HAIR SHAFT AND THE SCIENCE BEHIND COLORING

PRODUCTS:

Hair shaft is made up of three major components, from outermost to innermost layer – hair shaft cuticle, cortex and the medulla.

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1. Hair shaft cuticle – made up of thin flat keratinocytes. Forms a protective

barrier around the entire hair shaft.

2. Hair shaft cortex – gives shape and support to the hair structure, as it

contains bundles of keratin fibres, arranged in a vertical rod like fashion.

3. Hair shaft medulla – air filled space at the Centre of the shaft which has

no known biological function.

Hair colour is attributed to the presence of in the keratinocytes of the cortex (14).

Modification of hair colour can be obtained by two methods:

1. Removal of melanin pigment in cortex via bleaching

2. Addition of artificial pigment present in hair dye

Temporary dyes weakly adhere to the cuticle, but do not penetrate the cortex. This adherence is via van der Waals forces (weak attractions between atoms, molecules and surfaces due to change in polarizations of nearby particles)(15). As they only coat the hair, they are easily washed off by single shampooing.

Permanent dyes pass through the cuticle, penetrate deeper into the shaft and gets deposited completely into the cortex, by forming covalent and ionic bonds. They are colourless and undergoes oxidation to give various shades of brown to black colour (16).

Semi-permanent dyes in turn coat the cuticle by van der Waals forces like temporary dyes and partially infiltrates the cortex like permanent dyes. (1)

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DIFFERENCES BETWEEN PERMANENT AND SEMIPERMANENT

DYES:

TEMPORARY / PERMANENT DYES SEMI-PERMANENT DYES 1. Washed off easily after shampooing (once in temporary,4 1. Not easily removed by to 12 in semi- shampooing permanent). 2. These are colorless precursors and 2. These are direct dyes and requires require an oxidizing agent to give no chemical reactions to give color color. 3. Contains alkalizing agent other than ammonia like monoamine 3. Contains ammonia as alkalizing ethanolamine and sodium agent. carbonate. 4. Hydrogen peroxide concentration 4. Hydrogen peroxide concentration is lower than in permanent is higher. counterpart.

5. Less damaging to hair 5. More damaging to hair 6. Alkalizing agents are less effective 6. Alkalizing agent removes the in removing the natural pigment of natural pigment of hair hair and therefore they cannot give effectively. a lighter shade.

Role of developers:

Hydrogen peroxide in developers serves the following functions,

1. It causes swelling of hair cuticle and thereby allows diffusion of precursors

(colourless) into the hair cortex.

2. the natural melanin pigment.

3. Catalyses the oxidation of colourless precursor, giving rise to large

coloured molecules, which get trapped inside the hair cortex.

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EPIDEMIOLOGICAL PROFILE:

PPD has been considered as an important allergen to produce contact dermatitis for many decades. It can cause acute, subacute and chronic dermatitis.

The median prevalence of PPD positivity among dermatitis patients was found to be 4.3% in Asia,4% in Europe and 6.2% in North America (17,18,19). The sensitization prevalence to PPD ranged between 2% and 12%. It was observed that the prevalence was relatively higher in Asian men than in women. This could be due to frequent dyeing of hair than scalp hair in men, thereby increasing the risk of sensitization. In a study, it was reported that there was fourfold rise in

PPD prevalence over the last decade (20). Allergic contact dermatitis occurs in only small proportion of patients who are already sensitized, the prevalence varying from 1.7% to 6% (21) (22). But, the true incidence in a community is very difficult to be estimated because its diagnosis depends on several factors like demography, index of suspicion of the physician, availability of patch testing etc. The key stone in the management and prevention of allergic contact dermatitis lies in the early diagnosis of ACD and identification of the culprit allergen.

Recently, increased prevalence of PPD sensitization has been accompanied by noteworthy rise in para-toluene diamine sensitization (PTD) (23) (24). In recent years, frequency of positive patch test reactions to PPD has been increasing and cross sensitization to other contact allergens may occur. In India, hair dye was initially restricted to disguise the grey hairs among elders, but nowadays it’s been used greatly by younger people to experiment with their looks. Thus, allergic contact dermatitis to hair dye shows a higher incidence among all ages (25).

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Epidemiological studies to assess the adverse effects of hair dyes could not be specifically summarized, since people indulge in various occupations like Hair dressers, , cosmetic persons use multiple products during work. In a review by Khumalo et al, prevalence of contact dermatitis was seen in up to 80% of hair dressers in smaller studies and 16.4% in larger studies (26). The most common presentation was Hand dermatitis which may be not only due to sensitizing and irritant effects of hair dye ingredients, but also due to unsafe packaging, inadequate protection and ignorance of safe handling of these chemicals (26).

PATHOGENESIS OF CONTACT DERMATITIS TO HAIR DYE:

Hair dye can cause both irritant and allergic contact dermatitis. Irritant dermatitis is characterized by damage to cutaneous integrity with epidermal lesions varying in severity and inflammation in underlying dermis. There is no prior sensitization or immunological reactions needed in irritant contact dermatitis. CD may be acute or chronic. In chronic ICD, barrier function is disturbed and in acute ICD mediators like TNF-α.IL-1, IL-6, IL-8, IFN-γ, IL-2

AND GM-CSF are involved.

Allergic contact dermatitis occurs in a previously sensitized individual and is a delayed type of hypersensitivity reaction. Contact allergens are usually of smaller in size (<500 D) and so are capable of penetrating deeper through the skin it gets conjugated with autologous proteins followed by sensitization.

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ACD consists of two distinct phases:

1. Induction or sensitization phase

2. Elicitation phase.

Induction phase: an allergen (hap ten) penetrates the epidermal layer, picked up and processed by an antigen presenting cell. Most allergens in ACD requires minimal processing as they are of low molecular weight. The processed antigen is presented to T lymphocytes present in lymph nodes which gets differentiated into memory and effector T lymphocytes. These are released into the blood stream. When the same individual is exposed to the same antigen, he develops elicitation phase. The resultant inflammatory reaction develops clinically in 24-48 hrs. Activated keratinocytes present antigen to the specific memory T cells in the epidermis and elicit a rapid inflammatory response. Once acquired, sensitivity persists. activated keratinocytes secrete IL-1 and express HLA DR on their surface and augments the function of Langerhans cells.

CLINICAL FEATURES:

Hair dyes can cause irritant contact dermatitis, allergic contact dermatitis, photo contact dermatitis, contact urticaria, contact leukoderma. It may also lead to contact anaphylaxis(27). The symptoms usually begin within a few hours to 1-2 days after hair dye application. The common presenting symptoms are itching, redness, papules, vesicles and photosensitivity. The severity of symptoms ranges from mild itching to oedema of face, eyelids, blisters and exudation. Common sites involved are scalp, hairline margins, forehead, post auricular regions. In men

12 who use hair dyes for and , lesions occur over the face, neck, upper chest, upper arms or rarely it may be generalized. Various other presentations are air borne contact dermatitis like picture (involving eyelids, retro auricular folds and flexures especially cubital fossa), prurigo like lesions on extremities (in severe cases).

Most commonly young to middle aged individuals are affected. It has also been reported that Allergic contact dermatitis to hair dye occurs in children, though rare in the age group of 12-15 years (28). This is due to sensitization after temporary henna tattoos exposure. Adverse effects of hair dye can rarely present as non-eczematous conditions like lymphomatoid contact dermatitis to PPD containing hair dye (29) and body dysmorphic syndrome (30).

Jain et al, in his study using 200 hair dye users has concluded that hair dye is toxic to human lens and this observation was confirmed on animal experiments

(31). I t has been found that long term PPD exposure has been associated with renal impairment (20). In one study conducted by Hamdouk in a group of 72 , it was found 14% had renal impairment, 26.4% had proteinuria and 41.1% had hematuria. It can also lead to hypertension, skin changes and bronchospasm (32).

Hair dye can also cause depigmentation over the scalp, extending beyond the hair line to the neck. Ghosh et al, in his study reported 27.4% cases of hair dye induced chemical leukoderma (33). Hydrogen peroxide present in hair dyes can lead to damage to hair structure. Other hair dye ingredients like pyrogallol, resorcinol are potential allergens too according to Penchalaiah et al study on

13 sensitizers causing contact dermatitis (CD) (34). In India, in recent times permanent hair dyes had arouse as a major cause of suicidal poisoning (35). Such poisoning usually presents with severe rhabdomyolysis, cervico- facial oedema and renal failure. Studies conducted in recent times shows positive associations of hair dye use to various malignancies like bladder , leukaemia, myelo-dysplastic syndromes (23).

EVALUATION:

PATCH TEST:

Patch test was introduced by Joseph Jadassohn in 1896.

For irritant contact dermatitis:

Para-phenylene diamine, the main ingredient found in many permanent and some semi-permanent hair dyes would cause irritant contact dermatitis as well.

Patch testing containing PPD allergen can be tried to identify the cause.

For allergic contact dermatitis:

Disruption of epidermal barrier integrity is the first step in the events following contact with an allergen (37). Therefore, ACD is increased in elderly and atopic individuals. Patch test is the gold standard diagnostic method for allergic contact dermatitis. The immune basis of patch test is type 4 hypersensitivity reaction (38) (39). It is based on the principle that the primed antigen specific

T lymphocytes formed in sensitization phase will be present throughout the body.

Hence allergens applied to normal looking skin like upper back (site usually preferred) will reproduce immune response. The aim of patch test is to trigger an

14 immune response in an already sensitized individual by applying defined concentration of suspected allergen and evaluating the degree of response. A positive reaction to patch test confirms that the person has allergic contact dermatitis.

Upper back is the preferred site because, both allergic and irritant reactions are most easily provoked on this site, it is spacious and least disturbed. Other sites considered for patch test are lower back, upper arm, forearms, thighs. The amount of allergen used depends upon the concentration of allergen in the vehicle and the amount we apply to the skin. The allergens to be patch tested are placed on Finn chambers and fixed on the back such that chambers are in close contact with the skin (to ensure occlusion). The fixing tapes are chosen in such a way that they are non-occlusive, non-allergenic and non-irritant. Test sites are marked with skin markers so that the positions of allergens can be distinguished once the pressure effects have subsided. To avoid dislodging of patches patient should be instructed not to take bath for the duration of tests, and to avoid exercise and other vigorous activity. Care should be taken not to do patch test in patients with active eczema as it may decrease the threshold of activity and may produce nonspecific reactions. In the presence of eczema procedure should be done once they are cleared for at least a fortnight.

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INDICATIONS OF PATCH TEST:

1. Eczematous disorders where contact allergy is suspected or is to be excluded. 2. Eczematous disorders failing to respond to treatment as expected 3. Chronic hand and foot eczema 4. Persistent or intermittent eczema of the face, eyelids, ears and perineum. 5. Stasis eczema

Patch test is used to investigate drug reactions like drug rash, eosinophilia and systemic symptoms (DRESS), maculopapular rash and fixed drug eruption

(FDE) (40).

Before application, patient should be informed of 1) test objectives 2) avoiding wetting the test site3) avoiding activities causing excessive sweating 4) local symptoms like itching 5). Patients should be instructed not to be exposed to sun or other sources of UV light.

If the patients are on immunosuppressants or steroids, they should be stopped before patch testing as they may affect the positive response of the test.

However, prednisolone doses up to 15 mg is acceptable while doing a patch test.

The use of antihistamines is not a contraindication for patch testing. Patch testing is generally not done in pregnancy, though there are lack of evidences for adverse effects. It can be done in young children and even infants but with lesser number of suspected allergens due to insufficient space.

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Battery or series and types of chambers:

Indian battery series 1 and 2(ISB 1&2) were used for patch testing in our centre.

The allergens used in the series are prepared with better penetration and without local irritant side effects. Each allergen is prepared in a suitable vehicle and the most commonly used is petrolatum. This allows good occlusion, has low cost and keeps the allergens stable. Other vehicles that could be used are water, solvents (acetone, ethanol, methylethylacetone) and hydrophilic gel. When the allergens are in liquid form filter papers are used while testing.

PATCH TEST CHAMBERS:

Finn chambers:

The Finn chambers are available commercially as strips consisting of five or 10 discs which are made of aluminium incorporated with an acrylic hypoallergenic adhesive. The AL system consisting of filter paper discs mounted on an aluminized paper is not of use nowadays. Square and oval plastic chambers namely Van der bend chambers and Epicheck respectively are also available.

Curatest F is a water-resistant test available nowadays. TRUE is a ready to use kit based on the dispersion of allergens in a hydrophilic polymer. Chambers are prepared to avoid sensitization to their own material.

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Durat et al study shows substances with same chemical structure cross react and should not be tested next to each other (41). In the battery series, substances are kept in an order according to their chemical structures to avoid cross reactivity and co sensitization (42). After application, adhesive tapes can be used to prevent detachment due to increased sweating and false negative results(43).

The results must be differentiated from irritant reactions (which has no diagnostic value) as they may look identical. Certain clues like no infiltration, absence of itching, deep redness, sharp demarcation confined only to the allergen site all point towards irritant reaction. The results are read on day 2(48 hours) and day 4. Reading is done one hour after removal of the patch (for pressure effects of the strips to settle). Rarely, patients may develop a late reaction 1-3 week after the application of patch test e.g. in case of neomycin and corticosteroids. If late reactions occur patch test must be repeated after 4 weeks as it would be difficult to decide the exact allergen producing the late reaction.

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ANTIGENS USED IN INDIAN BATTERY SERIES:

1. 11. Paraben mix

2. Wood alcohol 12. Para-phenylenediamine

3. Balsam of Peru 13. Parthenium

4. Formaldehyde 14. Neomycin sulphate

5. Mercaptobenzothiazole 15. Benzocaine

6. Potassium bichromate 16. Chlorocresol

7. Nickel sulphate 17. Fragrance mix

8. Cobalt sulphate 18. Thiuram mix

9. Colophony 19. Nitrofurazone

10. Epoxy resin 20. Black rubber mix

READINGS AND INTERPRETATION:

ICDRG (international contact dermatitis research group scoring system)

- Negative

?+ doubtful Faint erythema only

+ Weak positive Palpable erythema, infiltration, possibly papules

++ Strong positive Erythema, infiltration, papules, vesicles

+++ Extremely positive Intense erythema, infiltration and coalescing

vesicles

NT Not tested

IR Irritant reaction

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FALSE POSITIVE REACTIONS:

• Excessive concentration of allergen

• Contaminants

• Irritant vehicle

• Recent dermatitis at patch test site

• Presence of dermatitis at distant sites

• Adhesive tape reactions

• Artefacts

• Angry back reaction- recent dermatitis at the test area or even other areas

lowers the threshold for irritant reactions and causes nonspecific irritant

reactions. Also called excited skin Syndrome.

FALSE NEGATIVE RESULTS:

False negative results may occur, and so negative result does not completely exclude the possibility of CD. Only statistically relevant substances are included in standard series, but the possibility of a rare or new sensitizing agent cannot be excluded (44) (45). Some causes of false negative results are:

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 Insufficient concentration of allergen

 Improper adhesion of patch

 Readings done too early

 Pretreatment at the patch test site with topical steroids

 UV exposure of patch test site and if the patient is on immunosuppressants

COMPLICATIONS OF PATCH TEST:

 Pruritus

 Folliculitis

 Flare of dermatitis

 Irritant reactions due to inappropriately diluted allergen

 Sensitization

 Hyper or hypo pigmentation

 Scarring and anaphylaxis

OPEN TEST:

Open test is to test allergic reactions to hair dye products 48 hours prior to the dye applications. Here a small amount of the dye is placed behind the ears and looked-for redness. The limitations of this test are, there are possibilities to miss patients who develop reactions beyond 48 hours and those who have weaker positive reactions.

21

SEMI-OPEN TEST:

This method is designed to evaluate substances with irritating properties like detergents, shampoos, dyes, glues, pharmaceuticals and cosmetics. A small amount of the substance is applied to 2*2cm area. After it is dried completely, the area is covered with adhesive tape for 2 days. The site is read after 48 and 96 hours.

REPEATED OPEN APPLICATION TEST (ROAT):

ROAT was first described by Hannuksela and Sato in 1986.It is used to refine the positive, negative or doubtful responses, obtained in the closed test (46).

Suspected commercial products (cosmetics or drugs), are applied twice a day for 7 days to sites like anterior portion of arm, antecubital fossa or scapular region.

Positive response in 2-4 days indicates presence of sensitizing substance.

PHOTO PATCH TEST:

This method is used to diagnose dermatitis in which Ultraviolet radiation

(UV) is an adjuvant.it is also called photoallergic CD. Here, allergens are applied on the back of the patient, removed after 48 hours.one side is covered with an opaque material. The uncovered site is exposed to UV radiation. The recommended dose used is 5 to 15 J/cm2.reading is taken 48 hours post irradiation.

22

PATCH TESTS IN SPECIAL SITUATIONS:

Patch tests in patients using immunomodulatory drugs:

The frequency of positivity for drug reactions varies from 7.5 to 54%, according to different studies, the patients selected, type of rash and drug involved

(47). In 2008, Rosmarin et al. described allergic contact dermatitis in hands in patients using

Anti-TNFα. The authors patch tested the patient and found positive results to various substances (48). Wee et al. patch tested 38 patients using different immunosuppressive drugs. Among them, 16 (44%) tested positive with intensity varying between (+) and (+ + +) (49).

Patch tests in children:

The most affected areas are the extremities and the most common allergens are metals, footwear, topical medication and cosmetics. The size of the child's back does not allow the placement of many allergens. The use of chambers designed at present is well established in this age group (50).

Most positive reactions (62%) obtained in young children (12 and 18 months of age) were not reproduced retested (3 and 6 years old). This suggests the potential irritating capacity of this allergen in young children (51).

23

COMPOUND ALLERGY:

Compound allergy refers to the condition where patch test is positive when done with a finished product but when patch tested with individual ingredients, it turns out to be negative. So, the finished product and its constituents should be patch tested if there is a strong suspicion.

QUENCHING:

This phenomenon is investigated mostly in fragrance material aldehyde. A combination of chemicals may lead to a quenching effect, as there may be potentiation of allergic and irritant responses. It may be due to one of the compounds having anti-inflammatory properties like triclosan having quenching effect on nickel ACD.

MULTIPLE PATCH TEST REACTIONS:

This is a quite common and may be due to non- specific hyperreactivity, multiple primary hypersensitivities and cross-reactions (true and false). Cross reactions is the phenomenon where sensitization to one primary compound

(primary allergen), extends to one or more compounds (secondary allergen) as a result of similarity in structure.

Chemicals that cross react with PPD:

Individuals sensitive to PPD show a relatively high risk of concurrent sensitivity to other chemically related hair dyes as well as clothing dyes.

24

CHEMICAL PRODUCT

Para-aminobenzoic acid Sunscreens

Sulfonamides, sulfonylureas Medications

Para-toluene diamine sulfate Semi-permanent hair dyes

Azo dyes Clothes, ballpoint pen ink, shoes

Benzocaine, tetracaine, procaine Local anesthetics

Para-amino salicylic acid Antibiotics

IN VITRO TEST:

Lymphocyte activation test (LAT) – described by Kneiling et al. Titrated amount of PPD with IL-2 supplementation are cultured with freshly isolated peripheral blood mononuclear cells. Proliferation of cells determined by minimum of three-and-a-half-fold raise in the uptake of [3H]-thymidine added to it confirms the individual is allergic to PPD.

COMPLICATIONS:

Secondary bacterial infection

Sensitization involving other areas

25

MANAGEMENT:

General measures:

 avoidance of hair dye product causing dermatitis.

 In case of acute dermatitis, hair is washed thoroughly with soap less

to remove excess hair dye.

 Frequent application of emollients

 In acute stage, saline compresses help in anti-pruritic action, reducing

oozing and removal of crust.

 Potassium permanganate soaks in severe infected lesions.

 Systemic antibiotics will be needed if secondary bacterial infection occurs

 Avoidance of over the counter topical preparations as they may contain

irritants like alcohol and propylene glycol

 Those who manifest with photosensitivity must be advised about regular

use of sunscreens over sun exposed areas. Additional protection by using

appropriate clothing’s and wide brim hats are to be advised.

 Usage of topical steroids in formulation gives symptomatic relief.

Super potent steroids in face and prolonged usage of steroids are better

avoided. Short course of systemic steroids are used in severe cases

 systemic anti -histamines may be required to alleviate itching.

 People should inform their hair dressers about their allergy.

 Patients could be suggested to safely wear wigs or fur coats dyed with

PPD.

26

 In case of occupational exposure, wearing of protective garments like

sleeved clothes, protective gloves.

PPD free alternative hair dyes:

An alternative dyeing agent which is tested for PPD sensitive individuals is

Hydroxyethyl-p-phenylenediamine sulfate, a recognized sensitizer(52).in one study in 216 individuals,19.9% reacted to 1%PPD,but 0.9% were positive to 1%HPPS, an alternative PPD derivative reported to be safe in those who even showed

3+ positive response to PPD. Synthetic formulations free of PPD may help in avoiding allergic contact dermatitis in sensitive patients. Henna ,a herbal hair dye is considered to have low allergic potential, however some of them may contain additives like diaminotoluenes and diaminobenzenes which may lead to contact dermatitis.

27

Aims & Objectives

AIMS & OBJECTIVES

STUDY OBJECTIVES:

1. To study the epidemiological pattern of contact dermatitis to hair dye.

2. To study the various presentations of contact dermatitis to hair dye.

3. To study the various allergens causing contact dermatitis to hair dye.

28

Materials and Methods

MATERIALS & METHODS

STUDY DESIGN

PROSPECTIVE STUDY

STUDY PLACE

Department of occupational and contact dermatitis Madras medical college Chennai

STUDY PERIOD

June 2017 to May 2018

ELIGIBILITY

INCLUSION CRITERIA

1. Patients attending or referred to occupational and contact dermatoses OPD

with a clinical suspicion of contact dermatitis to hair dye.

2. All patients with more than 18 years of age.

EXCLUSION CRITERIA

1. Patients less than 18 years of age.

2. Pregnant women

3. Patients with active dermatitis

4. Those patients on steroid treatment.

29

METHODOLOGY

This study was carried out as a clinical, epidemiologic and etiological survey of hair dye contact dermatitis from June 2017 to May 2018.

The sampling procedure is summarized as follows.

I. All patients attending occupational and contact dermatitis outpatient

department having signs and symptoms of hair dye contact dermatitis

between the study period are selected for the study as per the criteria

mentioned above and enrolled in the study.

II. The sample size for the study 43.

III. All the subjects were interviewed in person.

IV. Detailed case history of each patient with reference to

a. Age

b. Sex

c. Duration and course of the disease

d. Type of work

e. Address

f. Educational Status

g. Age at which first used Hair dye

h. Type of Hair Dye Used

i. Frequency of usage

j. Quantity used

k. Reaction after use

l. Past history

m. Treatment History

30

V. One of the senior and experienced professors helped to exclude conditions

like psoriasis, lichen planus and dermatophytosis clinically.

VI. Symptomatology assessment

Symptoms like itching, watery discharge, burning sensation and signs, sites

of involvement, morphology of lesions like oozing, scaling, crusting,

vesicles, hyperkeratotic, discoid lesions, pigmentation and history of other

skin. The presence of associated skin findings of atopy was noted.

VII. Risk factor assessment

VIII. History of endogenous factors like atopy is noted.

IX. History of exogenous factors like hair dye application is noted.

X. PATCH TEST

Patch test was done for all patients with kit containing Indian standard

series which is approved by contact and occupational dermatosis forum of India

and has twenty allergens.

 Patient ‘s upper back was chosen for application of patch test

 Before patch testing once again it was confirmed whether the patient is on

systemic steroids or other immunosuppressants.

 The patch made of non-allergenic, non-irritant, non-occlusive tape and

aluminum chambers named as Finn chamber.

 About 5 mm of solid antigen and in case of liquid antigen around 15

microliter or 0.1 ml was placed in the discs.

31

 The kit is available as two strips with each strip containing two columns of

antigen of five each.

 These two strips with the allergens were stuck to the patient’s upper back

 The antigens are numbered over the adhesive plaster with an indelible ink

 The corners of the patch were also marked on all the four sites which

would give us an idea whether the patch was displaced or not.

 The patients were advised not to take shower for the duration of test, and

avoid activities like exercise which would induce sweating and dislodge

the patches

 The patients were advised not to expose the patches to sun or other sources

of UV light.

 The patients were asked to come after 48 hours for reading

 The patches were removed and patient is made to wait for next one hour

for the erythema and edema developed due to pressure of the strips to

subside

 After removal of the patches, allergens are numbered over the body as their

positions cannot be distinguished once the pressure effects have subsided

 The readings are done and interpreted according to International contact

dermatitis research group scoring system which is as follows.

32

- Negative

?+ Doubtful, Faint erythema only Weak positive reaction + Palpable erythema, infiltration and papules Strong positive reaction ++ Erythema, infiltration, papules and vesicles Extreme positive reaction. Intense erythema, infiltration and +++ coalescing vesicles IR Irritant reaction

NT Not tested

 True allergic reactions were distinguished from irritant reaction by

presence of itching and infiltration, extension beyond the margins

 The patch test readings are noted and the person is advised to avoid the

particular allergen

 Patients were advised skin care and importance of regular application of

emollient

 Patients were advised protection measures like wearing gloves according to

the occupation.

 Patients were given appropriate treatment according to disease severity

 Ethical committee approval was obtained from the institute ethics

committee.

33

STATISTICAL ANALYSIS

The collected data was entered for analysis in Microsoft Excel. This data was exported to Statistical Package for Social Sciences software (SPSS) version

22.0. Mean, standard deviations and range were employed to describe continuous variables, while frequency distributions were obtained for dichotomous variables.

ETHICAL ISSUES

 All the Participants were made aware about the nature and purpose of the

study.

 It was also informed to all the participants that all data provided by the

patients were kept confidential and will be used only for the study purpose.

 Willingness and signature of the participants was taken on a previously

designed consent form.

 Written consent was obtained from all the subjects who participated in the

study before data are collected.

 Detailed description of the study and the aspects of patient confidentiality

were explained to the subject and voluntary participation is sought.

 Institutional ethics committee of Madras medical college reviewed the

study proposal for ethical consideration and approval of the committee was

obtained prior to the study.

34

Observations & Results

RESULTS

Table 1: Age distribution of the study subjects (n=44)

Frequency Percent Age group N % 31 - 40 years 8 18.2

41 - 50 years 20 45.5

51 - 60 years 16 36.4

Total 44 100.0

Mean (± S.D) Age: 48.55 ± 7.02 years

Minimum: 34 years Maximum: 60 years

Comments: About 63% of the subjects were aged between 31 to 50 years while the remaining were aged more than 50 years.

Fig 1: Age distribution of the study subjects (n=44)

18%

36% 31 - 40 years

41 - 50 years

51 - 60 years 46%

35

Table 2: Gender distribution of the study subjects (n=44)

Frequency Percent Group N %

Female 13 29.5

Male 31 70.5

Total 44 100.0

Comments: About 70% of the subjects were males.

Fig 2: Gender distribution of the study subjects (n=44)

30%

Female

Male

70%

36

Table 3: Distribution of the study subjects according to locality (n=44)

Frequency Percent Locality N % Rural 9 20.5

Urban 35 79.5

Total 44 100.0

Comments: About 80% of the subjects were from urban locality.

Fig 3: Distribution of the study subjects according to locality (n=44)

20%

Rural Urban

80%

37

Table 4: Distribution of the study subjects according to occupation (n=44)

Frequency Percent Occupation N % Professional 1 2.3 Semi-professional 1 2.3 Clerk/shop owner 8 18.2 Housewife 9 20.5 Skilled 13 29.5 Semi-skilled 4 9.1 Unskilled 8 18.2 Total 44 100.0

Comments: About 30% of the subjects were skilled workers while 20% of

the subjects were housewives and 18% were unskilled workers.

Table 5: Distribution of the study subjects according to education (n=44)

Frequency Percent Education N % Primary 2 4.5 Middle school 7 15.9

Secondary school 9 20.5

Higher secondary 3 6.8

Graduate/Diploma 20 45.5 Post-graduate & above 3 6.8

Total 44 100.0

Comments: More than half of the subjects were graduates or post-graduates while

27% of the subjects had secondary school education.

38

Fig 4: Distribution of the study subjects according to education (n=44)

Post-graduate & above 3

Graduate/Diploma 20

Higher secondary 3

Secondary school 9

Middle school 7

Primary 2

0 5 10 15 20 25

39

Table 6: Distribution of the study subjects according to previous history of contact dermatitis (n=44)

Frequency Percent Previous history N %

Present 3 6.8

Absent 41 93.2

Total 44 100.0

Comments: Only about 7% of the subjects had previous history of contact dermatitis.

Fig 5: Distribution of the study subjects according to previous history of contact dermatitis (n=44)

7%

Present

Absent

93%

40

Table 7: Distribution of the study subjects according to duration of contact dermatitis (n=44)

Frequency Percent Duration N %

<1 month 25 56.8

1m to 1 year 14 31.8

>1 year 5 11.4

Total 44 100.0

Comments: More than half of the subjects had contact dermatitis for a duration of less than a month.

41

Fig 6: Distribution of the study subjects according to duration of contact dermatitis (n=44)

30

25 25 <1 month

20 1m to 1 year

15 14 >1 year

10

5 5

0 Frequency

42

Table 8: Distribution of the study subjects according to duration of dye usage

(n=44)

Frequency Percent Duration of dye use N %

<1 year 10 22.7

1 to 5 years 21 47.7

6 to 10 years 9 20.5

>10 years 4 9.1

Total 44 100.0

Mean (± S.D) duration of dye use: 5.38 ± 4.0 years

Minimum: 2 months maximum: 30 years

Comments: About 70% of the subjects were using hair dye for duration of 1 to 5 years.

43

Fig 7: Distribution of the study subjects according to duration of contact dermatitis (n=44)

<1 year 1 to 5 years 6 to 10 years >10 years 25

21 20

15

10 10 9

5 4

0 Frequency

44

Table 9: Distribution of the study subjects according to brand of dye (n=44)

Frequency Percent Dye brand N %

Black henna 4 9.1

Black rose 12 27.3

Godrej 21 47.8

Garnier 3 6.8

Indica 8 18.2

Supervasmol 3 6.8

V care 1 2.3

Comments: About 48% of the subjects were using Godrej brand hair dye followed by Black rose brand (27%).

45

Table 10: Distribution of the study subjects according to frequency of dye application (n=44)

Frequency Percent Frequency of dye use N %

Weekly once 3 6.8

Once in 2 weeks 5 11.4

Once in 3 weeks 3 6.8

Once in a month 18 40.9

Once in 2 months 10 22.7

Once in 3 months 5 11.4

Total 44 100.0

Comments: About 41% of the subjects were using hair dye once in a month.

46

Fig 8: Distribution of the study subjects according to frequency of dye application (n=44)

Once in 3 months 5

Once in 2 months 10

Once in a month 18

Once in 3 weeks 3

Once in 2 weeks 5

Weekly once 3

0 5 10 15 20

47

Table 11: Distribution of the study subjects according to quantity of dye application (n=44)

Frequency Percent Quantity of dye used N %

10 ml 5 11.4

15 ml 2 4.5

20 ml 16 36.4

25 ml 2 4.5

30 ml 19 43.2

Total 44 100.0

Comments: About one-third (37%) of the subjects were using 20ml after reconstitution per session while 43% of subjects were using 30ml for each session.

48

Fig 9: Distribution of the study subjects according to quantity of dye application (n=44)

30 ml 19

25 ml 2

20 ml 16

15 ml 2

10 ml 5

0 5 10 15 20

49

Table 12: Distribution of the study subjects according to previous history of reaction after dye application (n=44)

Frequency Percent Reaction after dye use N %

No 25 56.8

Itching/ Pruritis 17 38.7

Raised lesion/pain/darkening of skin 2 4.5

Total 44 100.0

Comments: More than one-third (39%) of the subjects had Itching/ Pruritis immediately after application of hair dye.

50

Table 13: Distribution of the study subjects according to co-morbidities (n=44) Frequency Percent Co-morbidities* N %

Diabetes mellitus 7 15.9

Hypertension 2 4.6

Cataract 1 2.3

Hypertrophic LP/Prurigo nodularis 1 2.3

Trigeminal neuralgia 1 2.3

Pityriasis capitis 1 2.3

Facial melanosis 1 2.3

Acanthosis Nigricans 1 2.3

No comorbidities 33 75

* Not mutually exclusive

Comments: About 16% of the subjects had Diabetes mellitus.

51

Table 14: Distribution of the study subjects according to history of atopy (n=44)

Frequency Percent History of atopy N %

Absent 37 84.1

Present 7 15.9

Total 44 100.0

Comments: Among the 7 subjects with history of atopy, 4 subjects had history of seasonal wheezing since childhood, 1 subject had prurigo nodularis, 2 subjects had frequent episodes of urticaria and 1 subject had in addition allergy to dairy products.

52

Fig 10: Distribution of the study subjects according to history of atopy (n=44)

Absent

Present

16%

84%

53

Table 15: Distribution of the study subjects according to type of skin lesion (n=44)

Frequency Percent Type of skin lesion N %

Acute 6 13.6

Subacute 5 11.4

Chronic 23 52.3

No skin lesion 10 22.7

Total 44 100.0

Comments: More than half (52%) of the subjects had chronic skin lesions while roughly 23% did not have any skin lesion.

54

Fig 11: Distribution of the study subjects according to type of skin lesion

(n=44)

25

20

15

23 10

5 10 6 5

0 Acute Subacute Chronic No skin lesion

55

Table 16: Distribution of the study subjects according to clinical pattern of skin lesion (n=44)

Frequency Percent Clinical pattern of skin lesion N %

Localized contact dermatitis (scalp and scalp 10 22.7 margins) only

Face (beard, periorbital) and neck 8 18.2

Localized contact dermatitis + Face (beard, 21 47.7 periorbital) and neck involvement

Hands and feet 1 2.3

Air-borne contact dermatitis (ABCD) pattern 3 6.8

Miscellaneous patterns 1 2.3

Total 44 100.0

Comments: Roughly half (48%) of the subjects had localized contact dermatitis and involvement of skin in face (beard, periorbital) and neck.

56

Table 17: Distribution of the study subjects according to morphology of skin lesion (n=44)

Frequency Percent Morphology of skin lesion N %

No skin lesion 10 22.7

Multiple skin coloured papules with or without 3 6.8 erythema

Hyper-pigmented macules 5 11.4

Hyper-pigmented papules 11 25

Hyper pigmented/scaly plaques with or without 9 20.5 erythema

Urticarial plaque 1 2.3

Lesions with Crusted erosions/oozing/Fissuring 4 9.1

Hyper pigmented patch 9 20.5

Depigmented macules/papules/Leukoderma 1 2.3

Hypo-pigmented patch 2 4.6

Seborrheic melanosis 1 2.3

Angioedema 1 2.3

Lichenification/lichenified plaques 6 13.6

57

Table 18: Distribution of the study subjects according to patch test result

(n=44)

Frequency Percent Patch test N %

Positive* 39 88.6

Negative 3 6.8

Reading not taken 2 4.6 (patient not returned)

Total 44 100.0

*1 subject had allergic contact dermatitis to tape

Comments: Majority of the subjects (89%) had a positive patch test while 2 subjects did not return for followup.

58

Fig 12: Distribution of the study subjects according to patch test result

(n=44)

Positive Negative Reading not taken

4% 7%

89%

59

Table 19: Distribution of the study subjects according to patch test result for

PPD (n=42)

Frequency Percent Patch test for PPD N %

Negative 5 11.9

1+ 17 40.5

2+ 5 11.9

Pigmentation 14 33.3

Pigmentation and 1 + 1 2.4

Total 42 100.0

Comments: About one-third of the subjects (33%) had pigmentation response to patch test against PPD while more than half of the subjects (52%) showed 1+ or

2+ result against PPD antigen.

60

Fig 13: Distribution of the study subjects according to patch test result for

PPD (n=42)

Pigment and 1 + 1

Pigmentation 14

2+ 5

1+ 17

Negative 5

0 5 10 15 20

61

Table 20: Distribution of the study subjects according to patch test result for parthenium (n=42)

Frequency Percent Patch test for parthenium N %

Negative 38 90.5

1+ 3 7.1

3+ 1 2.4

Total 42 100.0

Comments: About 4 subjects (10%) had positive patch test for parthenium.

62

Table 21: Distribution of the study subjects according to patch test result for

Benzocaine (n=42)

Frequency Percent Patch test for Benzocaine N %

Negative 38 90.5

1+ 3 7.1

Doubtful 1 2.4

Total 42 100.0

Comments: About 3 subjects (10%) had positive patch test for Benzocaine while result of 1 subject was doubtful.

63

Table 22: Distribution of the study subjects according to patch test result for

Colophony (n=42)

Frequency Percent Patch test for Colophony N %

Negative 38 90.5

1+ 3 7.1

Doubtful 1 2.4

Total 42 100.0

Comments: About 3 subjects (10%) had positive patch test for Colophony while result of 1 subject was doubtful.

64

Table 23: Distribution of the study subjects according to patch test result for

Fragnance mix (n=42)

Frequency Percent Patch test for Fragnance mix N %

Negative 32 76.2

1+ 10 23.8

Total 42 100.0

Comments: About one fourth of the subjects (24%) had positive patch test for

Fragnance mix.

65

Table 24: Distribution of the study subjects according to patch test result for

Epoxy resin (n=42)

Frequency Percent Patch test for Epoxy resin N %

Negative 37 88.1

1+ 3 7.1

Doubtful 2 4.8

Total 42 100.0

Comments: About 3 subjects (10%) had positive patch test for Epoxy resin while result of 1 subject was doubtful.

66

Table 25: Distribution of the study subjects according to patch test result for

Mercaptothiazide (n=42)

Frequency Percent Patch test for Mercaptothiazide N %

Negative 38 90.5

1+ 1 2.4

Doubtful 3 7.1

Total 42 100.0

Comments: Only 1 subject had positive patch test for mercaptothiazide while 3

subjects had doubtful results.

67

Table 26: Distribution of the study subjects according to patch test result for other antigens (n=42)

Frequency Percent Patch test Antigen Result N %

Nickel 1+ 3 7.1

Nitrofurazone 1+ 2 4.8

Chlorocresol 1+ 1 2.4

Doubtful 1 2.4 Neomycin 1+ 1 2.4

Cobalt sulphate 1+ 1 2.4

Balsam of Pern 1+ 2 4.8

Black rubber Mix 1+ 2 4.8

Paraben mix 1+ 1 2.4

Potassium bichromate 1+ 3 7.1

Total 42 100.0

68

Table 27: Distribution of the study subjects according to patch test result and gender (n=42)

Total Female (n=12) Male(n=30) Patch test Antigen positives N (%) N (%) PPD 37 11 (91.7) 26 (86.7)

Fragnance mix 10 3 (25) 7 (23.3)

Epoxy resin 5 0 5 (16.7)

Parthenium 4 1 (8.3) 3 (10)

Benzocaine 4 1 (8.3) 3 (10)

Colophony 4 0 4 (13.3)

Mercaptothiazide 4 2 (16.6) 2 (6.7)

Potassium bichromate 3 - 3 (10)

Nickel 3 2 (16.6) 1 (3.3)

Neomycin 2 1 (8.3) 1 (3.3)

Nitrofurazone 2 1 (8.3) 1 (3.3)

Balsam of Pern 2 1 (8.3) 1 (3.3)

Black rubber Mix 2 0 2 (6.7)

Chlorocresol 1 0 1 (3.3)

Paraben mix 1 0 1 (3.3)

Cobalt sulphate 1 0 1 (3.3)

69

Clinical Images

Fig 1 : Papules over the neck

Fig 2 : Pigmentation and scaling in forehead and eyes

Fig 3 : Hyperpigmented papule over nape of neck

Fig 4 : Erythematous papules – face

Fig 5 : Patch test applied

Fig 6 : Angioedema lips Fig 7 : Leukoderma

Fig 8a : 1+ for fragrance mix Fig 8b : Pigmentation in and thiuram mix patch test for PPD

Fig 9 : Pustule seen in scalp

Fig 10 : 1+ for parthenium

Fig. 11 : 1+ for PPD Fig 12 : 1+ for PPD

Fig 13 : Pigmentation over the face

Discussion

DISCUSSION

Demographic variables:

The mean age in the current study was 58.5 years with an SD of 7 years.

The minimum age was 34 years while the maximum was 60 years.

This is similar to the mean age of 58.7 years with an SD of 9.6 years as observed in a study by Lee et al (53) with an objective to evaluate the safety of 15 commercial hair dye products by studying patch test results with commercial hair dye products in patients with allergic contact dermatitis to para- phenylenediamine. The mean age was slightly lower than one observed by Gupta et al (54) study (on 80 patients suspected to have contact allergy from hair dye using the patch test with Indian Standard series including PPD) as the mean age was 62 years ranging from 17 years to 74 years. The current study finding of 63% of the subjects between the age of 31 and 50 years is comparable to 42 % of the patients between 26 to 40 years as reported by Sadagopan et al (55). However the mean age in this study was much higher than 27.5 years as reported by Tomar et al (56).

Regarding Gender in the current study about 70% of the subjects were males while 30% were females. This finding is contrary to 43.5% men and 56.5% women as observed by Lee et al (53), 58% of males and the 42% females as observed by Gupta et al (54) and 59% males and 41 % females as reported by

Sharma VK et al (58) who studied the patch testing into 220 patients suspected of contact dermatitis.

70

About 80% of the subjects in the current study were from urban locality while Gupta et al (54) observed 58 % were from rural background and 42% were from urban background.

About 52% of the subjects were graduates or postgraduates while 27% of the subjects had Secondary School Education.

Occupation plays an important role in exposure and sensitization to allergens and in the current study, 30% of the subjects were skilled workers while

20% of the subjects were housewives and 18 % were unskilled workers.

Gupta et al(54) observed 57% of the males were skilled workers while 19 % were shopkeepers and 91% of the females were housewives and the remaining being students. Tomar et al (56) reported that 46 % of the subjects where students followed by 18 % housewife and 10% were teachers.

Only 3 out of 44 patients (6.8 %) had a previous history of contact dermatitis in the past. Regarding the duration of contact dermatitis 56.8% had dermatitis for less than a month while 11.4% had dermatitis for more than a year.

Roughly 32% have dermatitis with the duration of more than one month to less than a year. According to Gupta et al (54), the duration of dermatitis ranged from two weeks to 8 years with 33% of the subjects had dermatitis for more than one year duration while 52 % of the patients had dermatitis for more than one month and less than a year. Tomar et al (56) reported that 68% of the subjects had dermatitis for less than one year duration.

71

Roughly about 70% of the subjects were using hair dye for a duration ranging from one year to 5 years. According to Gupta et al (54), 14% where using the dye for less than a month whereas 21% were using the dye for more than

3 years and 52% of the subjects were using the dye for a duration ranging from one month and one year.

Regarding the brand of hair dye in the current study, 48% of the subjects were using Godrej while 27% were using black rose. About 41 percent of the subjects were using hair dye once in a month while 15 % were using once in a week or once in a fortnight. About one-third (37%) of the subjects were using 20 ml of the dye after reconstitution per session while 43% of subjects were using

30ml for each session.

More than one-third (39%) of the subjects had Itching/ pruritis immediately after application of hair dye. About 16% of the subjects had Diabetes mellitus while 5% had hypertension and one subject is reported cataract, Trigeminal

Neuralgia, acanthosis nigricans, facial melanosis, and prurigo nodularis.

Regarding the history of atopy, 84% of the subjects had a positive history while

16 % reported negative history.

Clinical pattern:

In this study more than half of the subjects (52%) had chronic skin lesions while roughly 23% did not have any skin lesion at all. Roughly half (48%) of the subjects had localized contact dermatitis and involvement of skin in face (beard,

72 periorbital) and neck. Only scalp and scalp margins were involved in localised contact dermatitis in about 22.7 % of the patients. Skin lesions involving face and neck including the periorbital area was observed in 18.2 % of the cases. Airborne contact dermatitis was observed in about 7 % of the patients while involvement of only hands and feet was observed in one subject. These findings can be corroborated with findings of Gupta et al (54) such as the most common presentation of the contact dermatitis was localized to scalp and scalp margins followed by dermatitis of face and neck and hands and feet. Airborne contact dermatitis was observed in 9 subjects. According to Tomar et al (56), the most commonly involved site for the skin lesions was the face followed by fore-head, scalp and neck. The commonest clinical pattern observed by Sharma VK et al(58) was Airborne contact dermatitis followed by hands and feet involvement.

With regards to morphology of the skin lesions among the 34 subjects

(no skin lesion observed in 10 subjects), Hyperpigmented papules was the commonest presentation as it was observed in 11 subjects followed by hyperpigmented patch (in 9 subjects) and hyper-pigmented plaques (in 9 subjects) besides lichenification /lichenified plaques observed in six subjects. Crusted lesions with oozing and/or fissuring was observed in four subjects. Atypical presentations like seborrheic melanosis, angioedema, depigmented macules / leucoderma and urticarial plaque was observed in one subject each.

73

Patch test:

Among the 44 subjects who were involved in the patch test about 39 subjects (88.6 %) where found to be positive for the patch test while 3 (6.8%) subjects reported negative results. Two subjects did not turn up for the patch test results. One subject reported an allergic contact dermatitis to the tape used in the patch test.

Lee et al (53) studied the 23 patients who completed the study and 87% had a positive patch test for at least one product. According to Gupta et al (54), out of the 80 subjects, 54 patients (67.5%) showed positive patch test result. Tomar et al(56) observed that patch test was positive in 66% of the patients while Jindal et al(57) observed that patch test was positive in 50% of the patients. Sharma VK et al

(58) observed that 82% of the subjects were positive for patch test.

In the present study, with regards to the commonest antigen allergen being

PPD, about 88% of the subjects showed a positive reaction. About 40% of the subjects should 1+ reaction in the patch test while 12% of the subjects showed 2 + reaction. One third of the subjects showed a pigmentation reaction for the PPT antigen. After PPD, 10 subjects (23.8 %) were positive for fragrance mix. Four subjects (9.5 %) had a positive patch test for parthenium whereas three subjects

(7.1) each were positive for benzocaine, Colophony, Epoxy resin, Nickel and potassium dichromate. Two subjects (4.8%) each were positive for Nitrofurazone, balsam of Peru, Black rubber mix and One subject (2.4%) each were positive for chlorocresol, neomycin, Cobalt sulphate and paraben mix.

74

The Korean standard antigen series was used by Lee et al (53) and all the patients showed positive patch test results to Para phenylenediamine (PPD) with

60.9% of patients showing 1+ reaction and 21.7 percent showing 2 + reaction the remaining 17.4% showed a positive 3 + reaction. 26.14% were positive for Nickel sulphate and 17.4 % where positive for neomycin sulphate. Fragrance mix was positive in 13% while potassium dichromate was positive in 13 % and balsam of

Peru was reported positive in 13 % of patients.

According to Gupta et al (54), 67.5% showed positive patch test results for

PPD. About 8 subjects showed a positive patch test for other allergens like 5 subjects had positivity for fragrance mix, 3 for thiuram mix and one each for paraben mix and colophony.

Sadagopan et al (55) studied 358 contact dermatitis patients with patch test and observed that 39 out of 57 of the construction workers were positive for

Potassium dichromate followed by Nickel and Cobalt. He also reported in other occupations, contact dermatitis to parthenium, hair dye, footwear, paint,and

Kumkum were also present in significant number.

Tomar et al (56) observed 50 patients of both sexes with clinically suspected cosmetic demo dieters using patch test with Indian Standard series and the commonest antigen allergen was Fragrance components 51.5 % including fragrance mix 27.2 % followed by 39.3 % preservatives (including 9 % parabens and 3 % Thiomersal) and 21.2% for PPD.

75

Among the most commonly used commercial hair dye, the ingredients present were PPD and Resorcinol. The next common ingredient found among our patients to cause allergy was fragrance mix.

Jindal et al (57) studied 34 patients with Venous Eczema and 10 controls for patch test with Indian Standard series and 10 topical medication. Patch test was positive in 50% of the patients with the commonest allergen being fragrance mix and PPD in 15% followed by Nickel, wool alcohol, Chino form in 9 %, and 5% in balsam of Peru and Cobalt 3 % in potassium dichromate, epoxy resin, formaldehyde and thiuram mix.

Sharma VK et al (58) reported that the most common test allergen was

Nickel sulphate (31%), parthenium (26%), potassium dichromate (15.7%, fragrance mix (11 %), nitrofurazone (10.7%) and Colophony in 9.3%.

Mercaptothiazide and neomycin was positive in 7.8% of the subjects.

LIMITATIONS OF THE STUDY

1) Since it’s a hospital-based study with a small sample size, the frequency of

manifestations may not reflect the actual population of the community.

2) Readings were not taken at 96 hours to observe late reactions.

3) Resorcinol was not tested in patch test.

4) Disadvantages of patch tests like false negatives and false positives had not

been mentioned.

76

Conclusion

CONCLUSION

 The total number of participants in our study were 43.

 Majority of the participants were males (70%) from urban locality (80%) and

30% of them were skilled workers.

 ACD to hair dye was more common in persons who have used hair dyes for

one to five years with a frequency of once in a month.

 More than one third of them had itching immediately after application of hair

dye and more than half of them had chronic skin lesions. This indicates the

importance of hair dye application subsequently in spite of symptoms.

 89% of the patients had positive patch test in which more than half of them

showed PPD positivity while one third had pigmentation response alone.

 PPD was found to be the common allergen in contact dermatitis to hair dye

which is in similar to other studies reported in Indian and world population.

77

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ABBREVIATIONS

ACD - ALLERGIC CONTACT DERMATITIS

PPD - PARA PHENYLENE DIAMINE

PABA - PARAAMINOBENZOICACID

PTD - PARA TOLUENE DIAMINE

ICD - IRRITANT CONTACT DERMATITIS

CD - CONTACT DERMATITIS

TNF - TUMOUR NECROSIS FACTOR

IL - INTERLEUKIN

IFN - INTERFERON

GM-CSF - GRANULOCYTE MACROPHAGE COLONY STIMULATING FACTOR

HLA - HUMAN LEUKOCYTE ANTIGEN

DRESS - DRUG RASH, EOSINOPHILIA AND SYSTEMIC SYMPTOMS

FDE - FIXED DRUG ERUPTION

ISB - INDIAN STANDARD BATTERY

LAT - LYMPHOCYTE ACTIVATION TEST

S. Previous Dye Dye duratn Dye Name Age Agegroup Sex Locality Occupation Occu. group Education duratn Duratn group Type of dye Frequency Qnty Reatnaftuse Comorbid others Personal HO Atopy No Ho duratn group duratnN

6 Nagammal 40 31 to 40 years F R HW HW 8. - 1m <1 month 3 M <1 year 0.25 Black rose 1m 10 SL,Pruritis - - - -

Black rose 7 Gnansekaran 52 51 to 60 years M U LIC agent skilled G - 1Y >1 year 10 Y 6 to 10 years 10 1m 15 Mild itch - - Occ.Alcoholic - Godrej Clerk,shop 13 Biju 44 41 to 50 years M U Clerk PG - 15d <1 month 4 Y 1 to 5 years 4 Godrej 1m 30 Mild itch - - - - owner

16 Kothraj 44 41 to 50 years M U Security Unskilled 12. - 1Y >1 year 2 Y 1 to 5 years 2 Black rose 1m 10 - - - - -

Clerk,shop 27 Saludeen 51 51 to 60 years M U Clerk G - 1w <1 month 4 Y 1 to 5 years 4 Black henna 3m 25 - - - - - owner

18 Mariya 40 31 to 40 years F U Nurse skilled G - 1m <1 month 5 Y 1 to 5 years 5 Godrej, Indica 2m 30 Mild itch - - - Urticaria

38 Ellapan 58 51 to 60 years M R Factory worker Semi-skilled G - 6m 1m to 1 year 5 Y 1 to 5 years 5 Indica 2m 30 - - - - -

Raised lesion,pain DM,HT,17y,I 20 Gajendran 55 51 to 60 years M U Police skilled G - 6m 1m to 1 year 8 Y 6 to 10 years 8 Indica 2w 20 - - - scalp nsulin Clerk,shop 23 Pandiyan 50 41 to 50 years M U Teashop owner 8. - 1y >1 year 3 Y 1 to 5 years 3 Supervasmol 1w 20 - - - - - owner 30 saraswathy 60 51 to 60 years F U HW HW 9. - 15d <1 month 1 Y <1 year 1 Black henna 2m 30 Mild itch - - - -

33 Chandra 50 41 to 50 years F R HW HW 7. - 1m <1 month 6m <1 year 0.5 Black rose 2m 20 - - - - -

40 Kathirvel 45 41 to 50 years M R Farmer Unskilled 8. - 3m 1m to 1 year 2 Y 1 to 5 years 2 Black rose 1m 20 - - - - Present

Scaling thumb, 1 Vivek 55 51 to 60 years M U Driver skilled 10. - 3m 1m to 1 year 3 Y 1 to 5 years 3 V33, Vcare 3m 20 Nil except last DM,7m scaly plaque in Occ.Alcoholic - palm Scalp pityriasis Wheezing 8 Rabin 45 41 to 50 years M U Driver skilled G - 3m 1m to 1 year 5 Y 1 to 5 years 5 Godrej 1m 20 Mild itch - - capitis children

Black rose 15 Rajendran 58 51 to 60 years M U Security Unskilled 10. Y 6m 1m to 1 year 10 Y 6 to 10 years 10 2w 25 - cataract - - - Godrej

5 Latha 42 41 to 50 years F U HW HW 12. - 2m 1m to 1 year 3 Y 1 to 5 years 3 Black rose 2m 20 Mild itch - - - -

19 Doss 42 41 to 50 years M U Security Unskilled 10. - 10d <1 month 2 Y 1 to 5 years 2 Indica 2m 30 - - - - -

Clerk,shop 24 Gunaseelan 39 31 to 40 years M U Clerk G - 4m 1m to 1 year 5 Y 1 to 5 years 5 1m 30 - HT,7y - - - owner

Kamalakanna 32 41 41 to 50 years M U Supervisor skilled G - 1m <1 month 6 Y 6 to 10 years 6 Godrej 1m 30 - - - - - n

Hypertrophic prurigo 9 Alagarsamy 60 51 to 60 years M U Driver skilled 8. - 3m 1m to 1 year 15 Y >10 years 15 Indica 2m 20 - LP, prurigo - - nodularis nodularis,1y S. Previous Dye Dye duratn Dye Name Age Agegroup Sex Locality Occupation Occu. group Education duratn Duratn group Type of dye Frequency Qnty Reatnaftuse Comorbid others Personal HO Atopy No Ho duratn group duratnN

Godrej,Indica,Bl 36 Dhananjayan 50 41 to 50 years M U Port worker Unskilled G - 1y >1 year 3 Y 1 to 5 years 3 3w 30 Mild itch - - - - ack rose

39 Annadurai 57 51 to 60 years M U Driver skilled G - 1y >1 year 7 Y 6 to 10 years 7 Godrej 2w 30 Itching - - - -

12 Hemamalini 45 41 to 50 years F U HW HW PG - 10d <1 month 5 Y 1 to 5 years 5 Godrej 2m 30 - DM,4y - - -

29 Kanniyappan 48 41 to 50 years M U Constructn work Unskilled 10. - 10d <1 month 1 Y <1 year 1 Black rose 1m 20 - - - - -

Vishwanatha Clerk,shop 3 58 51 to 60 years M U Clerk G - 1m <1 month 5 Y 1 to 5 years 5 Godrej 1m 15 Nil except last DM - - - m owner

14 Amarjothi 50 41 to 50 years F U HW HW 12. - 1m <1 month 7 Y 6 to 10 years 7 Godrej 3w 20 - DM,5y - - -

Clerk,shop 22 Sulaimann 46 41 to 50 years M U Textile business G - 1m <1 month 6 Y 6 to 10 years 6 Garnier 1m 30 - - - - - owner

34 Vijayakumar 50 41 to 50 years F U farmer Unskilled 9. - 15d <1 month 1 Y <1 year 1 Black henna 1m 20 - - - - -

Clerk,shop 17 Pandiyan 58 51 to 60 years M U shopowner 5. Y 3m 1m to 1 year 20 Y >10 years 20 Godrej 3w 10 - - - - - owner

25 Anjalai 60 51 to 60 years F R HW HW 10. - 10d <1 month 20 Y >10 years 20 Black rose 3m 20 - - - - -

31 Pathan 50 41 to 50 years M U Hotelwork Semi-skilled G - 1m <1 month 3 Y 1 to 5 years 3 Godrej 1m 30 - - - - -

35 Elangovan 50 41 to 50 years M U Electrician skilled ITA - 6m 1m to 1 year 7 Y 6 to 10 years 7 Godrej 2w 30 Itching - - - Present

41 Kanimozhi 38 31 to 40 years F U salesperson Semi-skilled G - 1m <1 month 1 Y <1 year 1 Black henna 1m 30 Itching - - - -

44 Subramani 47 41 to 50 years M R Supervisor skilled G - 1w <1 month 4 Y 1 to 5 years 4 Godrej 3m 30 - - - - Present

10 Karunakaran 55 51 to 60 years M R Farmer Unskilled 10. - 1m <1 month 4 M <1 year 0.33 Godrej 1w 10 Itch,darkening DM,5y - - -

11 Joshua 40 31 to 40 years M R Mechanic skilled 10. - 2m 1m to 1 year 3 Y 1 to 5 years 3 Godrej 2m 20 - - - - -

21 Rajendran 49 41 to 50 years M U Executive export Semi G - 2d <1 month 30 Y >10 years 30 Godrej,Garnier 1w 30 - DM,5y - - -

Geethakrishna Trigem.Neur 26 54 51 to 60 years M U Librarian Professional G - 1w <1 month 10 Y 6 to 10 years 10 Godrej 2m 20 - Facial melanosis - - n algia Allergy to Clerk,shop 28 Velmurugan 53 51 to 60 years M U Fruitseller 8. - 1d <1 month 2 M <1 year 0.16 Indica 1m 20 - - - - dairy owner products S. Previous Dye Dye duratn Dye Name Age Agegroup Sex Locality Occupation Occu. group Education duratn Duratn group Type of dye Frequency Qnty Reatnaftuse Comorbid others Personal HO Atopy No Ho duratn group duratnN

37 Shanthi 40 31 to 40 years F U Cust.care Semi-skilled PG - 2w <1 month 6m <1 year 0.5 Godrej 1m 30 Itching - - - -

Acanthosis 4 Parvathy 43 41 to 50 years F R HW HW 10. - 6m 1m to 1 year 2 Y 1 to 5 years 2 Black rose 1m 10 Mild itch - - - Nigricans

2 Mahesh 52 51 to 60 years M U Tailor skilled 10. Y 2m 1m to 1 year 4 Y 1 to 5 years 4 Black rose 3m 20 Mild itch - - - -

42 Chandrasekar 34 31 to 40 years M U mechanic AC skilled ITA - 2w <1 month 2 Y 1 to 5 years 2 Indica 1m 30 - - - - -

Supervasmol, 43 Vijaya 38 31 to 40 years F U HW HW G - 1w <1 month 1 Y <1 year 1 2w 30 Itching - - - - Godrej S. Complaints Lesion Group Site Clinical.pattern Morphology Patch Patch test PPD Parthenium Benzocaine Colophony Chlorocresol Frag. Mix Epoxyresin Mercaptothiazide Nitrofurazone Other Patch No

Postauricular,Nape raised skin lesn in neck 6 SA neck,Forehead, back, ABCD pattern Scaly ery plaq, Pig papule No reading No reading 0 ------face arms Face (beard, periorbital) and Hyp.Pig.Patch , Seborr 7 Itching scalp, Pig face C Postauricular, Face No reading No reading 0 ------neck melanosis Localized contact dermatitis 13 Itching scalp NSL NSL - Negative Negative 0 ------(scalp and scalp margins)

Localized contact dermatitis 16 Itching scalp,concha,back NSL NSL - Negative Negative 0 ------(scalp and scalp margins)

Localized contact dermatitis 27 Itching scalp NSL NSL - Negative Negative 0 ------(scalp and scalp margins)

Alergic contact Scalp,Face,Nape neck, Face (beard, periorbital) and 18 Itching scalp,neck,face C Hyp.Plaq,Hyp.Pig.Patch dermatitis to Positive Pig ------Forehead neck tape

Itching scalp, dark raised Scalp, ear lobule, forearm, Face (beard, periorbital) and Lichenified plaque, Pig.on Black rubber 38 C - Positive Pig + 1 ------skin lesn scalp forehead,nose neck hand,forearm, De.Pig scalp mix:1+ raised skin lesn in scalp, Scalp,Face,Nape neck, Face (beard, periorbital) and Hyp.Pig,Multiple papules, Neomycin: 20 C - Positive Pig - - - - 1. - - - moustache Forehead neck Pig doubtful Face (beard, periorbital) and Hyp.Pig multiple 23 dark skin lesn in neck C Scalp,Neck,chest - Positive Pig ------neck papules,macules Face (beard, periorbital) and 30 Itching scalp,face,neck C Neck,forehead,temple Pigmented macules - Positive Pig ------neck Itching scalp, Hyp.Pig multiple Nickel:1+,Balsa 33 C Neck,forearms,arms ABCD pattern - Positive Pig ------photosensitivity papules,macules m of Pern:1+ Itching scalp, dark raised Face (beard, periorbital) and Lichenification neck, 40 C Nape neck,back, occiput - Positive Pig - - - - - Doubtful - - Parabens:1+ skin lesn scalp, neck neck Hyp.Pig,Multiple papules

Localized contact dermatitis Hyp.Pig.Patch , Excoriatn 1 Itching scalp, redness eye C Upper back, Nape neck - Positive Pig 3+ Doubtful 1+ 1+ - - - - - (scalp and scalp margins) marks

Localized contact dermatitis Hypo,hyper pig.Patch , 8 Itching scalp, back C Upper back - Positive Pig - - 1. ------(scalp and scalp margins) Excoriatn marks

Itching scalp, Excoriatn, scalp, moustache,Nape Lichenified plaque, 15 Pigmentn skin scalp, C neck,forearm,forehead ABCD pattern Hyp.Pig,Multiple papules, - Positive Pig - - - - - 1. - - - moustache cheek darkening of skin

Localized contact dermatitis 5 Itching scalp NSL NSL - - Positive Pig - 1. - - 1. - 1. - - (scalp and scalp margins)

Localized contact dermatitis 19 Itching scalp NSL NSL - - Positive Pig - - - - 1. - - 1 - (scalp and scalp margins)

Localized contact dermatitis 24 Itching scalp NSL NSL - - Positive Pig ------(scalp and scalp margins)

Localized contact dermatitis 32 Itching scalp NSL NSL - - Positive Pig ------(scalp and scalp margins) S. Complaints Lesion Group Site Clinical.pattern Morphology Patch Patch test PPD Parthenium Benzocaine Colophony Chlorocresol Frag. Mix Epoxyresin Mercaptothiazide Nitrofurazone Other Patch No

raised skin lesn in scalp, Forehead, Neck, Face, Face (beard, periorbital) and 9 C Hyp.Pig.Patch, papules - Positive Pig ------face, neck Ears concha neck

scalp, De.Pig multiple White lesions scalp, neck, Face (beard, periorbital) and Balsam of 36 C moustache,beard,neck,ba papules,macules - Positive 2 - - - - 1. - - - moustache neck Pern:1+ ck (leukoderma) Lichenification neck, peri- Itching, dark discolor skin Face (beard, periorbital) and 39 C face,scalp, neck, beard orbi,paranasal, - Positive 2 ------face,scalp, neck neck Hyp.Pig,Multiple papules Itching scalp, raised skin Postauricular,Forehead, Face (beard, periorbital) and 12 A Ery.scaly plaq, oozing - Positive 2 ------lesn scalp Neck neck Itching Raised skin lesn Face (beard, periorbital) and Crusted Potassium 29 A Scalp,moustache - Positive 2 - - - - - Doubtful - - scalp, moustache neck erosions,pustules,oozing bichromate:1+

Itching scalp, Skin discolor Face (beard, periorbital) and 3 forehead,moustache,chee C Forehead, Neck, Face Hyp.Pig.Patch - Positive 2 - - - - 1+ 1+ - - - neck k Face (beard, periorbital) and 14 dark skin lesn in neck face SA Nape neck Ery.scaly plaq - Positive 1 ------1 - neck Itching, White lesions scalp, Face (beard, periorbital) and Skin colored papules,Plaq, Cobalt sulphate 22 face,scalp, Raised skin SA moustache,forehead, - Positive 1 - - 1. - - - - - neck Depig, scaling 1+ lesn face cheek, Postauricular Itching Raised skin lesn Forehead,neck, Face (beard, periorbital) and multiple Skin colored 34 SA - Positive 1 ------Neomycin:1+ scalp, moustache, beard moustache, beard neck papules,Plaq, scaly ery Plaq

Itching scalp, dark raised Nape neck,neck fold, Face (beard, periorbital) and Dark Hyp plaque, 17 C - Positive 1 - 1. - - - - Doubtful - - skin lesn scalp,neck,chest chest neck Hyp.Pig,Multiple papules Hyp.Pig multiple Arms,Palms,forehead,Post 25 dark skin lesn in neck,face C Hands and feet papules,macules, - Positive 1 ------Doubtful - - auricular Hyp.Pig.Patch dark raised skin lesn Temple forehead hair Face (beard, periorbital) and Hyp.Pig multiple 31 C - Positive 1 ------forehead,neck, back line,neck, back, palms neck papules,macules Forehead,periorbital Face (beard, periorbital) and Hyp.Pig,Multiple papules, Potassium 35 Itching, dark discolor skin C region face,Forearms, - Positive 1 - - Doubtful - - - - - neck Pig dichromate:1+ moustache, beard Itching scalp, dark raised Face (beard, periorbital) and Lichenification, 41 C Post-auricular,scalp - Positive 1 ------Nickel:1+ skin lesn post=auri neck Hyp.Pig.scaly plaq

Itching scalp, Pig Face,moustache,beard,ch Face (beard, periorbital) and Hyp.Pig multiple Black rubber 44 C - Positive 1 - - - - 1. - Doubtful - face,beard,moustache eek,scalp,back neck papules,Plaq, Hyp.Pig.Plaq mix:1+ Itching scalp, face, scalp,temple, forehead, Face (beard, periorbital) and Lichenified plaque, 10 back,moustache skin C - Positive 1 ------cheek, moustache neck Hyp.Pig,Multiple papules Darkening Skin discolor scalp, face, Postauricular,face,scalp, Face (beard, periorbital) and 11 C Hypo,hyper pig.Patch - Positive 1 - - - - 1. - - - - neck back neck Miscellaneous patterns 21 Swelling upper lip A Upper lip discoid dermatitis erythema Urticarial plaq - Positive 1 ------multiforme?like lesions S. Complaints Lesion Group Site Clinical.pattern Morphology Patch Patch test PPD Parthenium Benzocaine Colophony Chlorocresol Frag. Mix Epoxyresin Mercaptothiazide Nitrofurazone Other Patch No

Itching scalp, oozing dark Face,neck,moustache,Post Face (beard, periorbital) and 26 A oozing Hyp.Plaq, Fissuring, - Positive 1 1. 1. ------raised skin lesn neck,face auricular,occipital hairline neck

Peri-orbital,perioral Peri-orbital,perioral Face (beard, periorbital) and 28 A Angioedema - Positive 1 1. ------swelling, itching swelling, itching neck

Itching Raised skin lesn Forehead(hairline), multiple Skin colored ery Face (beard, periorbital) and 37 face,post=auri, pusfilled A temple, cheeks, forearms, papules,Plaq, crusted - Positive 1 ------neck lesn scalp arms,scalp,post-auri erosions, scaly plaque

Localized contact dermatitis 4 Itching, Scaling in scalp NSL NSL - - Positive 1 1. - - - 1. - - - - (scalp and scalp margins) Itching scalp, raised skin Postauricular,Nape Face (beard, periorbital) and Hyp.Plaq,Hyp.Pig.Patch, 2 SA - Positive 1 ------lesn in neck back neck,Forehead neck Pig Nickel:1+, Localized contact dermatitis 42 Itching scalp NSL NSL - - Positive 0 - - - - 1. 1. - - Potassium (scalp and scalp margins) dichromate:1+

Localized contact dermatitis 43 Itching scalp NSL NSL - - Positive 0 - - - - 1. - - - - (scalp and scalp margins)

KEY TO MASTER CHART

F - FEMALE

M - MALE

R - RURAL

U - URBAN

HW - HOUSEWIFE

PG - POST GRADUATE

G - GRADUATE

SL - SKIN LESION

LP - LICHEN PLANUS

SA - SUBACUTE

A - ACUTE

C - CHRONIC

NSL - NO SKIN LESION

ABCD - AIR BORNE CONTACT DERMATITIS

P - PIGMENTATION

DM - DIABETES MELLITUS

PROFOMA

Case No:

Name: Age: Sex: OP No:

Address:

Occupation:

Educational Status:

Age at which first used Hair dye:

Type of Hair Dye Used:

Frequency of usage:

Quantity used:

Reaction after use:

Past history:

Treatment History: History of steroid Treatment

General Examination:

Systemic Examination:

DERMATOLOGICAL EXAMINATION:

Site of Involvement: Distribution: Morphology of the lesions: Others:

INVESTIGATIONS: Patch Test:

TREATMENT GIVEN: Symptomatic

\ INFORMATION TO PARTICIPANTS

Investigators : Dr. K. SUDHA Dr. S. NIRMALA Dr. K. DEEPA

Name of Participant:

Title: “A STUDY ON HAIR DYE CONTACT DERMATITIS-ITS CLINICAL PRESENTATIONS AND ALLERGENS”

You are invited to take part in this study. The information in this document is meant to help you decide whether or not to take part. Please feel free to ask if you have any queries or concerns

We are conducting a study on “A STUDY ON HAIR DYE CONTACT DERMATITIS-ITS CLINICAL PRESENTATIONS AND ALLERGENS” among patients attending Rajiv Gandhi Government General Hospital, Chennai.

 And for that your participation may be valuable to us.

 The purpose of this study is to determine the epidemiology, clinical profile, various allergens causing contact dermatitis to hair dye.

 In this study history of patient will be taken, examination will be done and clinical photographs will be taken without disclosing the identity of patients,  Patch test will be done and results will be interpreted.

 The privacy of the patients in the research will be maintained throughout the study. In the event of any publication or presentation resulting from the research, no personally identifiable information will be shared.

 Taking part in this study is voluntary. You are free to decide whether to participate in this study or to withdraw at any time; Your decision will not result in any loss of benefits to which you are otherwise entitled.

 The results of the special study may be intimated to you at the end of the study period or during the study if anything is found abnormal which may aid in the management or treatment.

Signature of Investigator Signature of the Participant

PATIENT CONSENT FORM

Title of the Study: “A STUDY ON HAIR DYE CONTACT DERMATITIS-ITS CLINICAL PRESENTATIONS AND ALLERGENS”

Name of the Participant :

Name of the Principal investigator : DR.K.SUDHA

Name of the Institution : Rajiv Gandhi Government General Hospital, Chennai

Documentation of the informed consent

 I have read the information in this form (or it has been read for me). I was free to ask any questions and they have been answered. I am over 18 years of age and exercising my free power of choice, hereby give my consent to be included as a participant in the study.  I have read and understood this consent form and the information provided to me.  I have had the consent document explained to me.  I have been explained about the nature of the study.  I have been explained about my rights and responsibilities by the investigator.  I am aware of the fact that I can opt out of the study at any time without having to give any reason and this will not affect my future treatment in this hospital  I hereby give permission to the investigators to release the information obtained from me as result of participation in this study to the sponsors, regulatory authorities, government agencies and IEC.I understand that they are publicly published  I have understood that my identity will be kept confidential if my data are publicly presented.  I have had my questions answered to my satisfaction.  I have decided to be in the research study  I am aware that if I have any question during this study, I should contact at one of the addresses listed above. By signing this consent form I attest that the information given in this document has been clearly explained to me and apparently understood by me. I have given a copy of this consent document.

Name and signature/thumb impression of the participant (or legal representative if participant incompetent)

Name Signature Date

Name and signature of impartial witness (required for illiterate patients):

Name Signature Date

Address and contact number of the impartial witness:

Name and Signature of the investigator or his representative obtaining consent:

Name Signature Date

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PLAGIARISM CERTIFICATE

This is to certify that this dissertation work titled “A STUDY ON HAIR

DYE CONTACT DERMATITIS-ITS CLINICAL PRESENTATIONS AND

ALLERGENS” of the candidate Dr. SUDHA K, with registration Number

201630009 for the award of M.D DERMATOLOGY, VENEREOLOGY &

LEPROSY in the branch of XX. I personally verified the urkund.com website for the purpose of plagiarism Check. I found that the uploaded thesis file contains from introduction to conclusion pages and result shows 3 percentage of plagiarism in the dissertation.

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