Open‐label, single‐arm, single‐center clinical study on the effectiveness and safety of a moisturizer containing tocotrienol‐rich composition in children with mild to moderate atopic dermatitis

Abstract

BackgroundLittle is known about antioxidant efficacy of topical vitamin E on atopic dermatitis (AD) due to lack of controlled clinical studies.AimThe study evaluates the effectiveness and safety of a topical moisturizer containing tocotrienol‐rich composition over 12 weeks on patients aged between 1 month and 12 years with mild to moderate AD.MethodsWe conducted a 12 weeks, prospective, open‐label clinical study on the effect of tocotrienol as an adjunct to conventional treatment. This study was approved by the Ethics Committee for Research Involving Human Subject. JKEUPM‐2019‐274 (NMMR‐19‐1588‐49234).ResultsThirty AD patients with a mean age of 2.77 ± 3.05 were enrolled in the study. At week‐12, significant reduction of investigator global assessment (63.4%), Patient‐Oriented Scoring Atopic Dermatitis Index (PO‐SCORAD) (65%), and SCORAD (52.3%) was noted (p < 0.05). There was also a significant decreased in pruritus intensity (46%, p < 0.05). Similarly at week‐12, Infant's Dermatitis Quality of Life Index and Children's Dermatology Life Quality Index were found to improve significantly compared to baseline (p < 0.05). Instrumental assessment revealed improvement in TEWL and erythema index, 49.7% and 17.4%, respectively. No adverse reaction was observed. 95% of patients were satisfied with the moisturizer and 90% perceived it to be better than the one in the market. There was a 55.07% reduction in the use of hydrocortisone 1% cream toward the end of the study (p < 0.05).ConclusionsThe results suggested that tocotrienol‐rich moisturizer is safe and effective in the management of AD in young children.