Biomedical Research and Therapy, 5(11):2811-2819 Original Research Evaluation of the efficacy of a topical chamomile-pumpkin oleogel for the treatment of plaque psoriasis: an intra-patient, double-blind, randomized clinical trial ∗ 1 2; 3 4 5 Sima Kolahdooz , Mehrdad Karimi , Nafiseh Esmaili , Arman Zargaran , Gholamreza Kordafshari , Nikoo Mozafari6 , Mohammad. Hossein Ayati7 ABSTRACT Background: Plaque psoriasis is a chronic inflammatory skin disease. Conventional treatments of 1Department of Iranian Traditional psoriasis are not completely effective. In addition, unwanted side effects limit their long-term use. Medicine, School of Iranian Traditional In this regard, developing new natural treatments with fewer side effects could be an alternative Medicine, Tehran University of Medical option. This study was designed to evaluate the efficacy and safety of topical chamomile-pumpkin Sciences, Tehran, Iran oleogel (ChP) in treating plaque psoriasis. Methods: A total of 40 patients with mild-to-moderate 2Department of Iranian Traditional plaque psoriasis were enrolled in this intra-patient, double-blind, block-randomized clinical trial. In Medicine, School of Iranian Traditional each patient, bilateral symmetrical plaques were treated with ChP or placebo twice daily for four Medicine, Tehran University of Medical weeks. For clinical assessment, the Psoriasis Severity Index (PSI) and the Physician's Global Assess- Sciences, Tehran, Iran ment (PGA) scale were evaluated at baseline and after the treatment. At the end of the study, pa- 3Autoimmune Bullouse Diseases tients' satisfaction with the treatment was evaluated using a visual analog scale (VAS) ranging from 0 Research Center, Razi Hospital, Tehran to 10. For safety assessment, all treatment-related side effects were recorded. Results: Thirty-seven University of Medical Sciences, Tehran, subjects (20 female, 17 male; age 20–60 years) completed the study. The mean decreases in the PSI Iran score in the ChP group (4.09 2.24)were significantly (p = 0.000) greater than the placebo group 4 (0.48 1.39). According to the PGA results, 13/37 (35%) of the ChP-treated plaques could achieve Department of Traditional Pharmacy, School of Iranian Traditional Medicine, marked to complete improvement compared to 0% in the placebo group. Three patients dropped Tehran University of Medical Sciences, out from the study due to worsening of bilateral plaques during the first week of trial. Conclusion: Tehran, Iran Our results suggest that topically applied ChP could provide a safe and effective complementary 5 option for psoriasis plaque management. IRCT registration code: IRCT2016092830030N1. Department of Iranian Traditional Key words: Plaque psoriasis, Chamomile, Pumpkin Medicine, School of Iranian Traditional Medicine, Tehran University of Medical Sciences, Tehran, Iran Correspondence INTRODUCTION mainstay of mild psoriasis management and adjunct Mehrdad Karimi, Department of Iranian to systemic treatments in severe cases 7. The most Traditional Medicine, School of Iranian Psoriasis is a chronic and complex autoimmune skin frequently anti-psoriasis topical drugs are corticos- Traditional Medicine, Tehran University disease with a prevalence of 2–4% in the world 1. The of Medical Sciences, Tehran, Iran teroids, vitamin A derivatives, vitamin D analogues, most prevalent (up to 90%) sub-type of this disease calcineurin inhibitors, and coal tar. Unfortunately, Email: [email protected] is plaque psoriasis, which is characterized by raised most of these drugs cause unwanted side effects History erythematous scaly skin patches 2. The infiltration of • Received: 13 September 2018 such as skin irritation, infections, malignancy, at- dysregulated immunocytes in the skin layers and sub- • Accepted: 15 October 2018 rophy, purpura, telangiectasia, photosensitivity, and • sequent inflammation is responsible for the develop- Published: 19 November 2018 rebound symptoms 8. Given that psoriasis is life- ment of clinical plaques 3. These plaques tend to be DOI : long relapsing and difficult-to-treat-disorder, devel- symmetrically distributed on extensor areas of scalp, https://doi.org/10.15419/bmrat.v5i11.499 oping new alternative treatments with fewer side ef- 4 elbows, trunk, and knees . fects and higher efficacy is necessary 9. In this re- Although this disease is not life-threatening, it has gard, the use of traditional, complementary, and al- major negative impacts on the patient’s psychosocial ternative (TM/CAM) modalities is promising. Recent 5 health . Psychological distress and disability in this studies have shown that the demand for such treat- Copyright condition are not necessarily related to disease sever- ments among psoriasis patients has increased in the © ress. This is an open- Biomedp ity, and even mild psoriasis can have a great impact 10 access article distributed under the last decades . 6 terms of the Creative Commons on the well-being of patients . Iranian Traditional medicine (ITM) is one of the most Attribution 4.0 International license. In conventional medicine, topical or systemic med- ancient traditional systems of medicine with a history ications and phototherapy are administered based of thousands of years 11. In ITM, plaque psoriasis is on the severity of psoriasis. Topical therapy is the classified as a subtype of a disease named Ghouba 12. Cite this article : Kolahdooz S, Karimi M, Esmaili N, Zargaran A, Kordafshari G, Mozafari N, Ayati M H. Eval- uation of the efficacy of a topical chamomile-pumpkin oleogel for the treatment of plaque psori- asis: an intra-patient, double-blind, randomized clinical trial. Biomed. Res. Ther.; 5(11):2811-2819. 2811 Biomedical Research and Therapy, 5(11):2811-2819 6Skin Research Center, Shahid In ITM textbooks, herbal oils such as pumpkin (Cu- Traditional chamomile oil was prepared based on the Beheshti University of Medical curbita pepo L.) seed oil and chamomile (Matricaria direct heat method, which was standardized in pre- Sciences, Tehran, Iran chamomilla L.) oil (aqueous chamomile extract in vious studies 21,22. In this method, chamomile flower 7Department of Iranian sesame oil vehicle) are recommended for topical man- was powdered and boiled in water to achieve an aque- Traditional Medicine, School of agement of psoriasis 13. ous extract. Then, after filtering the mixture, the Iranian Traditional Medicine, The therapeutic effects of topical chamomile on in- aqueous extract was mixed with sesame oil and then Tehran University of Medical 14 boiled to evaporate all water content. The remaining Sciences, Tehran, Iran flammatory skin conditions such as atopic eczema , diaper rash 15,16 radiation dermatitis 17 and phlebitis 18 oil is called chamomile oil. Also, standard pumpkin have been documented in several studies. However, seed oil was purchased from the Giah Essence Phy- studies on the topical dosage forms of pumpkin seeds topharm Co., Iran. are limited. In an animal model of chronic skin in- flammation, topical pumpkin seed oil could reduce Inclusion and exclusion criteria edema, congestion, cells infiltration, and keratinocyte We enrolled 40 patients of both sexes using the eligi- hyperproliferation as well as dexamethasone 19. bility criteria listed in the Table 1. To date, no study has investigated the therapeutic ef- fect of topical preparations of chamomile or pump- Randomization and blinding kin seed oil on psoriasis. However, the documented To ensure balance in the treatment side (left or right), anti-inflammatory effects of chamomile 20 and pump- block randomization with a 1:1 ratio and block size kin seed oil 19 provide hypothetical support for their of four participants was performed. The principal probable therapeutic effect on plaque psoriasis. This investigator prepared sequentially numbered, sealed, study was designed to evaluate the efficacy of a semi- opaque envelopes for allocation of treatment. The in- solid topical herbal preparation made from the afore- vestigators and patients remained unaware of treat- mentioned herbal oils (ChP) on plaque psoriasis. ment allocation. The codes of ChP and placebo were only revealed after the trial was completed. METHODS Intervention Study design The patients first signed the written informed consent. This randomized intra-patient double-blind placebo- Then symmetrical target lesions in each patient were controlled clinical trial was conducted at the De- selected to receive ChP or placebo, twice daily for four partment of Dermatology at the Razi Hospital of weeks. the Tehran University of Medical Sciences, between September 2017 and March 2018. Outcome assessment Ethical issues A dermatologist who was blind to randomization scored the severity of erythema, scaling, and indura- This clinical trial was conducted in compliance with tion of plaques with an 8-point scale (0 = none, 2 = the Declaration of Helsinki. The study protocol was mild, 4 = moderate, 6 = severe, 8 = very severe). The reviewed and approved by the Research Ethics Com- response to the treatment was evaluated based on the mittee of the Tehran University of Medical Sciences mean reduction in the erythema, scaling, induration, (approval code: IR.TUMS.VCR.REC.1395.184). This and PSI scores from baseline. The PSI score is the sum study was registered at the Iranian Registry of Clini- of erythema, scaling, and induration score, and ranges cal Trials website (IRCT2016092830030N1). After ex- from 0 to 24. plaining the purpose of the trial to the patient, written In addition, we used the Physician’s Global Assess- informed