Department of Dermatology, Venereology Leprosy

Dr. B.R. AMBEDKAR MEDICAL COLLEGE K.G.HALLI, BANGALORE-560 045 DEPARTMENT OF DERMATOLOGY, VENEREOLOGY & LEPROSY

The Principal, Dr. B.R. Ambedkar Medical College, Bangalore

Dear Sir,

Sub: Proforma for registration of subject for dissertation

I hereby enclose the proforma for registration of subject for dissertation of Dr. ALI MOGHADDAMI RAD, post graduate student in M.D. Dermatology, Venereology & Leprosy, titled “EFFECTIVENESS OF TRICHLOROACETIC ACID PEEL IN THE TREATMENT OF POST ACNE HYPERPIGMENTATION ON THE FACE." .

I kindly request you to forward it to the Rajeev Gandhi University of Health Sciences, Bangalore for the needful.

Thanking you Yours faithfully,

Dr. Madan Mohan. N.T Associate Professor Department of Dermatology, Venereology & Leprosy Dr. B.R. Ambedkar Medical College Dr. B.R. AMBEDKAR MEDICAL COLLEGE K.G.HALLI, BANGALORE-560 045 DEPARTMENT OF DERMATOLOGY, VENEREOLOGY & LEPROSY

The Ethical committee, Dr. B.R. Ambedkar Medical College Bangalore

Dear Sir,

Sub: Proforma for registration of subject for dissertation

I hereby enclose the proforma for registration of subject for dissertation of Dr. ALI MOGHADDAMI RAD, post graduate student in MD Dermatology, Venereology & Leprosy, titled “EFFECTIVENESS OF TRICHLOROACETIC ACID PEEL IN THE TREATMENT OF POST ACNE HYPERPIGMENTATION ON THE FACE."

I kindly request you to review the protocol and issue an ethical clearance certificate for conducting the research work.

Thanking you Yours faithfully,

Dr. Madan Mohan. N.T Associate Professor Department of Dermatology, Venereology & Leprosy Dr. B.R. Ambedkar Medical College

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES BANGALORE, KARNATAKA

PROFORMA FOR REGISTRATION OF SUBJECTS OF DISSERTATION

1. Name of the candidate and address: (in Dr. ALI MOGHADDAMI RAD, block letters) No. 12, second floor, 4th Main, 4th Cross, Dr. Ambedkar Layout, R.T. Nagar post, Bangalore -560 032

2. Name of the institution Dr. B.R. AMBEDKAR MEDICAL COLLEGE & HOSPITAL, K.G. HALLI, BANGALORE-560 045

3. Course and Subject M.D. DERMATOLOGY VENEREOLOGY & LEPROSY

4. Date of admission 1st June 2009

5. Title of the dissertation Effectiveness of Trichloroacetic Acid peel in the treatment of post acne hyperpigmentation on the face. BRIEF RESUME OF INTENDED WORK

6.1 NEED FOR STUDY

Post acne hyperpigmentation is a common sequel in acne patients, more so in those with skin of color. Unlike acne scars, post acne hyperpigmentation is reversible.

However, it may take months (3-24 months) to resolve spontaneously.

It was noted in 65.3% of Blacks, 52.7% of Hispanics, and 47.4% of Asians in a study of acne in the USA.

Although post acne hyper-pigmentation is believed to be equally common in Indian patients, such data is not available for acne patients in India.

This study is conducted to know the effectiveness of Trichloroacetic acid in the management of post acne hyperpigmentation. The data collected from this descriptive study could be used for further studies.

Hence, I am conducting this study in the department of Dermatology, Venereology and Leprosy at Dr. B. R. Ambedkar Medical College and Hospital.

6.2 REVIEW OF LITERATURE

Acne occurs in all races worldwide, affecting 90% of people in different severities, sometime or the other, in their life. [1]

Dermatologists are aware that acne is a chronic disease with important ramifications.

Factors include stress-related production of adrenal androgens, Propionibacterium acnes colonization, familial background, and specific subtypes of acne (scalp folliculitis, chloracne, inversa).[2], [3]

Studies show that, approximately 60% of acne cases are self-limiting, and can be managed with acute treatment followed by topical maintenance therapy. [4]

Post inflammatory hyperpigmentation is a common sequel in acne patients, more so in those with skin of color. Unlike acne scars, PIH is reversible. [5]

Epidermal hyperpigmentation may (melanocytic epidermal hyperpigmentation) or may not (melanotic epidermal hyperpigmentation) be associated with an actual increase in the number of melanocytes. [6]

Although the exact cause of epidermal hyperpigmentation in inflammation has not been conclusively determined, it may be due to arachidonic acid metabolites that induce epidermal melanocytic proliferation, and activated tyrosinase activity due to some unknown factors. [6], [3]

Hyperpigmentary skin disorders on exposed parts of the body, especially the face, may produce a severe cosmetic defect, and mental stress and may demand urgent dermatological consultation and intervention. [6]

Chemical peeling is the application of a chemical agent to the skin that causes controlled destruction of a part of the epidermis, with or without the dermis, leading to exfoliation, followed by subsequent resurfacing of the epidermis and remodeling of the dermis. [7]

Chemical peeling is a simple and safe office procedure. Trichloroacetic acid (TCA) is a common peeling agent used for superficial as well as medium depth peels. [8]

TCA (also known as trichloroethanoic acid) is an analogue of acetic acid in which the three hydrogen atoms of the methyl group have all been replaced by chlorine atoms. It is a strong acid & is easily available as crystals, which are dissolved in distilled water to make a solution. It is stable, not light sensitive, but has deliquescent properties and hence old crystals exposed to air should not be used. [9]

Patients with a dry skin and a fair complexion are the best subjects. A variety of preparation of differing concentration can be used alone or in combination, depending on the desired outcome. Trichloroacetic acid is probably the most commonly used agent. [10]

The mechanism of action is coagulation and precipitation of the proteins leading to necrosis, degeneration and destruction of epidermis (keratin layer and keratinocytes) and dermis (cellular and connective tissue of papillary and upper reticular dermis- depending upon the depth achieved). Partial thickness wounds heal by re- epithelization from residual adnexal epithelium or epithelium derived from adjacent uninjured skin. This process begins within 24 hours of wounding and is complete by a week’s time in superficial to medium depth peels. [11]

It is caustic and causes coagulation of skin proteins leading to frosting. Precipitation of proteins leads to necrosis and destruction of the epidermis. [12]

According to Mark Rubin classification, TCA peel in a concentration of 10%-15% is used for very superficial peels (stratum corneum), a concentration of 15%-25% is used for superficial peels (epidermal), and a concentration of 35%-50% is used medium depth peels (papillary dermal). [11]

The effect of TCA peel can be evaluated on the basis of lightening of the hyperpigmentation scars. Improvement is judged on the basis of patient’s subjective score. It is as follows-

Significant improvement (greater than 75% clearance of lesions), Moderate improvement (51-75% clearance),

Mild improvement (26-50% clearance),

Minimal improvement (1-25% clearance), and

No response. [13]

6.3 OBJECTIVES OF THE STUDY

To study the efficacy of Trichloroacetic acid peel in the patients with post inflammatory hyperpigmentation in acne.

MATERIALS AND METHODS

7.1 SOURCE OF DATA

Patients with postinflammatory hyperpigmentation in acne from the

Department of Dermatology, Venereology & Leprosy in Dr. B .R. Ambedkar

Medical College & Hospital, K. G. Halli, Bangalore.

7.2 METHODOLOGY OF COLLECTION OF DATA

All patients with post acne hyperpigmentation attending the in patient and out

patient departments of Dermatology would be consented and included into the

study. Each patient will undergo three sittings of TCA peel every three weeks.

The first sitting is with 10% TCA peel, following which their responses will be recorded. The next two sittings will be done with 15% TCA peel, following which their responses will be recorded again.

Effect of TCA peel will be evaluated on the basis of lightening of the hyperpigmentation. Improvement will be judged on the basis of patient’s subjective score. It will be as follows:-

Significant improvement (greater than 75% clearance of lesions),

Moderate improvement (51-75% clearance),

Mild improvement (26-50% clearance),

Minimal improvement (1-25% clearance), and

No response.

The following are the key features of this study-

1. Present study will be carried out for 12 months.

2. Cases will be numbered serially and photographed, before & after

chemical peel.

3. Readings obtained will be recorded and tabulated.

4. Results obtained will be correlated and statistically analyzed.

Materials-

Trichloroacetic acid (10%), Trichloroacetic acid (15%), spirit, acetone, cold water, gauze sponges, syringe filled with water, soap, towels, plastic sheets, glass beaker.

Procedure- 1) Pre-peel

a) Consent will be taken and explanation regarding the occurrence of

a burning sensation and frosting of the skin during the procedure, with

skin becoming normal in 20-30 minutes; peeling of the skin in

ensuing days which should not be deliberately pulled off and the strict

adherence to sun protection measures for 1-2 weeks will be adviced.

Patient will be instructed to inform immediately if solution enters the

eye or if severe, burning sensation develops during procedure, for early

termination.

b) Preparation

i) Repeated washes with soap and scrub drying (atleast twice)

ii) Patient adviced to lie supine with head elevated at an angle of 45º.

Eyes are closed and ears are plugged with cotton.

iii) The area is scrubbed with spirit gauze twice followed by single

cleansing with acetone soaked gauze to ensure complete defatting.

2) Peel

a) The stocked TCA solution of desired concentration is poured into the

glass beaker. Gauze sponge is immersed in this solution.

b) It is applied with smooth strokes sequentially and unit wise- forehead,

right cheek, chin, left cheek, glabella, nose, perioral area, upper

and lower eyelids. This is done gently and upto/into the borders, and

/or margins of eyebrows, hairline, vermillion border and

submandibular region.

c) Reaction A reaction will be watched for, which may take several minutes to

appear, and consists of erythema/blanch/white frosting. Usually,

reaction is terminated after uniform frosting is observed.

d) Termination

The fan is switched on. The area is neutralized with cold water gauze

sponge. When necessary, patient is asked to continue dabbing cold

water till the burning sensation subsides and then pat the face dry.

Patient is advised to avoid rubbing.

3) Post-Peel

a) On completion, underlying skin is erythematous. Protection from

sunlight with sunscreens and moisturizers will be advised for 1-2

weeks and patient will be followed up weekly for observing peeling

and is prescribed accordingly.

b) At home- cold water/ice compresses, calamine lotion will be given for

drying and soothing.

c) Patient is adviced to use very mild soap on face.

Sample size study, design and duration-

This is a descriptive study, to be done on fifty patients with post acne hyperpigmentation, over a period of one year that is from 15th December 2010 to 15th December 2011. 7.3 INCLUSION CRITERIA

1. Patient between the age of 16-25 years.

2. Patients diagnosed as grade I & II acne with post acne hyperpigmentation.

3. Patients who have consented to undergo the procedure.

7.4 EXCLUSION CRITERIA

1. Active bacterial infection in the area to be peeled.

2. Active herpes simplex.

3. Viral warts or molluscum contagiosum on the area to be peeled.

4. Open wounds, inflammation or irritation.

5. History of taking photosensitive drugs.

6. Patients on systemic retinoids.

7. Patient with unrealistic expectations.

8. Steroid induced acne.

9. Patients on treatment for endocrine disorders.

10. Patients with irritant contact dermatitis to TCA.

11. Patients with keloids.

12. Grade V & VI type skin.

13. Psychiatric disorders. 8. LIST OF REFERENCES:

1. Burton JL, Cunliffe WJ, Stafford I. The prevalence of acne vulgaris in

adolescence. Br J Dermatol 1971;85:119-26.

2. Kligman A. Postadolescent acne in women. Cutis 1992;48:218-22.

3. Till AE, Goulden V, Cunliffe WJ, Holland KT. The cutaneous microflora of

adolescent, persistent and late-onset acne patients does not differ. Br J Dermatol

2000;142:885-92.

4. Niemeier V, Kupfer J, Demmelbauer-Ebner M, Stangier U, Effendy I, Gieler U.

Coping with acne vulgaris: evaluation of the chronic skin disorder questionnaire

in patients with acne. Dermatology 1998;196:108-15.

5. Nordlund JJ, Boissy RE, Hearing VJ, King RA, Oetting WS, Ortonne JP. “The

pigmentary system: Physiology and pathophysiology. 2nd ed. 2006 Malden, MA,

USA: Blackwell Publishing.

6. Dhar S. Pigmentary disorders. In: Valia RG, Valia AR, editors. IADVL

Textbook of dermatology. 3rd ed. Mumbai: Bhalani Publishing House; 2008. p.

790-91.

7. Savant SS. Superficial and medium depth chemical peeling. In: Savant SS, editor.

Textbook of dermatosurgery and cosmetology. 2nd ed. Mumbai: ASCAD; 2005. p.

177-95.

8. Brody H. History of Chemical Peels. In: Baxter S, editor. Chemical peeling and

resurfacing. 2nd ed. St. Louis: Mosby Year Book Inc.; 1997. p. 1-5.

9. Khunger N. Chemical Peeling. In: Valia RG, Valia AR, editors. IADVL Textbook

of dermatology. 3rd ed. Mumbai: Bhalani Publishing House; 2008. p. 1683-85.

10. Coleman WP III, Futrell JM. The glycolic acid- trichloroacetic acid peel. J Dermatol Surg Oncol 1994;20:76-80.

11. Rubin MG. ”What are skin peels”. In: Winters SR, James M, Caputo GR, editors.

Manual of Chemical Peels Superficial and Medium depth. 1st ed. Philadelphia: JB

Lippincott Co.; 1995. P. 17-25.

12. Khunger N. Step by step chemical peels. 1st ed. Delhi: Jaypee Brothers Medical

Publishers; 2009. p. 90-121.

13. Al-Waiz MM, Ddsc and Al-Sharqi AI. Medium-depth chemical peels in the

treatment of acne scars in dark-skinned individuals. Dermatol Surg 2002;28:383-

9. Signature of the Candidate

10. Remarks of the Guide

11. 11.1 Name & Designation Assoc. Professor Of the Guide (In Block Dr. Madan Mohan. N.T Letters)

11.2 Signature

11.3 Co-Guide if any

11.4 Head of the Department Prof. Nataraj. C. Hiremath

11.5 Signature

12. 12.1 Remarks by the Principal

12.2 Signature