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The Formulation and Efficacy of Topical Dorema Ammoniacum in Treating Melasma: A Randomized Double-Blind, Placebo-Controlled Trial Publisher Pubmed



Javedan K1 ; Hydarpur F2 ; Mohammadi Pour P3 ; Najafi F4 ; Mirzaeei S1 ; Rahimi R5 ; Gravandi MM6 ; Farzaei MH1
Authors
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Authors Affiliations
  1. 1. Pharmaceutical Sciences Research Center, Health Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran
  2. 2. Medical Biology Research Center, Health Technology Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran
  3. 3. Department of Pharmacognosy, School of Pharmacy and Pharmaceutical Sciences, Isfahan University of Medical Sciences, Isfahan, Iran
  4. 4. Faculty of Medicine, Kermanshah University of Medical Sciences, Kermanshah, Iran
  5. 5. Pharmaceutical Sciences Research Center, Tehran University of Medical Sciences, Tehran, Iran
  6. 6. Research Committee, Kermanshah University of Medical Sciences, Kermanshah, Iran

Source: Journal of Complementary and Integrative Medicine Published:2022


Abstract

Objectives: An acquired melanin-related hyperpigmentation that occurs in sun exposure areas is Melasma which presents as gray-brown ridges and macules with prominent margins on the skin. The aim of this assay was to assess the formulation and efficacy of topical Dorema ammoniacum among Melasma patients. Methods: This study was a 30 days double-blind, randomized clinical trial in Melasma with a placebo group. The study was carried out on 49 patients with Melasma attending Haji Daii Nursing Center in Kermanshah, Iran. Optimized topical formulation of D. ammoniacum gum extract was prepared by evaluating the characteristics of different topical formulations of this plant. Mean Melasma severity index (MMASI) instrument was applied to assess the product effectiveness and to determine the skin stains. Patients were pursued to receive the treatment throughout the 30 days trial. This scaling was accomplished before the intervention and 30 days after the use of the herbal product. To analyze the quantitative variables, t-Test and Mann-Whitney test were evaluated by SPSS 21 software, and p-value <0.05 was considered as the statistically significant. Results: The survey was performed on 40 female subjects (81.6%) and nine male subjects (18.4%) with the mean age of 32.18 ± 8.69. According to the results, the mean MSI in the drug group was significantly lower than before treatment and decreased from 86.98 ± 69.48 to 31.03 ± 32.62 (p-value <0.05). Conclusions: In compliance with findings this survey revealed a positive effect of the cream formulation of D. ammoniacum extract on Melasma. As it was represented no side effects, this formulation is appropriate for the treatment of Melasma. © 2021 Walter de Gruyter GmbH, Berlin/Boston.
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