Shirin Abbasi1, Mohammad Kamalinejad2, Delara Babaie3, SeyedMohammad Shams4, Zahra Sadr5, Mehdi Gheysari6, Vahid Reza Askari7, Hassan Rakhshandeh8. 1. Department of Persian Medicine, School of Persian and Complementary Medicine, Mashhad University of Medical Sciences, Mashhad, Iran. 2. School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran. 3. Department of Allergy and clinical immunology, Mofid Children's hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran. 4. Department of Biomedical Engineering, Faculty of Engineering, South Tehran Branch, Islamic Azad University, Tehran, Iran. 5. Firouz Abadi Hospital, Iran University of Medical Sciences, Tehran, Iran. 6. Skin Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran. 7. Pharmacological Research Center of Medicinal Plants, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran; Department of Pharmacology, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran. Electronic address: askariv941@mums.ac.ir. 8. Pharmacological Research Center of Medicinal Plants, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran. Electronic address: rakhshandehh@mums.ac.ir.
Abstract
BACKGROUND:Atopic dermatitis (AD) is a common, chronic, relapsing and inflammatory skin disease characterized by pruritus and xerosis (dry skin). Its prevalence is on the increase worldwide, particularly in children. As the pathogenesis of AD involves a complex interaction of genetic, environmental and immunological factors, its definitive treatment is difficult. OBJECTIVE: This clinical trial was designed as equivalence study to investigate the effect of aqueous extract of edible dried fig fruit on the severity of AD as measured with scoring atopic dermatitis (SCORAD), in comparison with Hydrocortisone 1.0% as the routine treatment of AD and base cream as a placebo. METHOD: Forty five children aged 4 months to 14 years with mild to moderate AD (SCORAD <50) were randomly assigned, in a double blind manner, to three treatment groups in order to perform a randomised, double blinded, placebo-controlled clinical trial. The patients were instructed to apply their allocated creams twice a day for two weeks. RESULTS: The randomised, placebo-controlled trial indicates that the new treatment had significantly increased efficacy in terms of reducing the SCORAD index, pruritus and intensity scores in comparison with Hydrocortisone 1.0% (p<0.05) and the placebo failed to ameliorate the symptoms. CONCLUSION:Safety, efficacy, tolerability, and symptom relief were considerable in fig fruit extract in comparison with hydrocortisone 1.0%. This clinical trial suggests that fig fruit extract can be used instead of low potent corticosteroid in mild to moderate cases of AD.
RCT Entities:
BACKGROUND:Atopic dermatitis (AD) is a common, chronic, relapsing and inflammatory skin disease characterized by pruritus and xerosis (dry skin). Its prevalence is on the increase worldwide, particularly in children. As the pathogenesis of AD involves a complex interaction of genetic, environmental and immunological factors, its definitive treatment is difficult. OBJECTIVE: This clinical trial was designed as equivalence study to investigate the effect of aqueous extract of edible dried fig fruit on the severity of AD as measured with scoring atopic dermatitis (SCORAD), in comparison with Hydrocortisone 1.0% as the routine treatment of AD and base cream as a placebo. METHOD: Forty five children aged 4 months to 14 years with mild to moderate AD (SCORAD <50) were randomly assigned, in a double blind manner, to three treatment groups in order to perform a randomised, double blinded, placebo-controlled clinical trial. The patients were instructed to apply their allocated creams twice a day for two weeks. RESULTS: The randomised, placebo-controlled trial indicates that the new treatment had significantly increased efficacy in terms of reducing the SCORAD index, pruritus and intensity scores in comparison with Hydrocortisone 1.0% (p<0.05) and the placebo failed to ameliorate the symptoms. CONCLUSION: Safety, efficacy, tolerability, and symptom relief were considerable in fig fruit extract in comparison with hydrocortisone 1.0%. This clinical trial suggests that fig fruit extract can be used instead of low potent corticosteroid in mild to moderate cases of AD.