Efficacy of Short Term Topical Malva Sylvestris L. Cream in Pediatric Patients with Atopic Dermatitis: A Randomized Double-Blind Placebo-Controlled Clinical Trial

Abstract

Background: Atopic dermatitis (AD) is a chronic inflammatory pruritic dermatologic disease in children. Malva sylvestris L. (M. sylvestris) is a medicinal plant, which is used as a remedy for eczema in traditional Persian medicine. Previous studies have shown the anti-ulcerogenic and anti-inflammatory activity of this plant. Objectives: We designed a clinical trial to evaluate the efficacy of topical cream of the M. sylvestris extract in the management of children with AD. Methods: Fifty-one children with AD were randomly enrolled in two arms of a randomized, double- blind, controlled clinical trial. They were treated by topical cream of the M. sylvestris extract or placebo for a palm-sized surface (single fingertip unit, twice daily) for 4 weeks. The SCORing Atopic Dermatitis (SCORAD) score was set as the primary outcome measure. Results: There was a significant improvement in the severity of participants’ dermatitis regarding skin thickening score, redness score, and total SCORAD score of the M. sylvestris group as compared with the placebo group (P= 0.009, P=0.01, and P=0.03; respectively). Conclusion: According to the results of this clinical trial, it could be concluded that the topical use of M. sylvestris extract cream was effective in the reduction of AD symptoms in children. Trial Registration: This study is registered by the Iranian Registry of Clinical Trials with the code: IRCT20170107031814N2.