Abstract
INTRODUCTION: Atopic dermatitis (AD) is a chronic relapsing disease with a pathophysiology including skin barrier damage, microbiome disbalance and inflammation. Classically, emollients maintaining a healthy microbiome are recommended as the basis of any AD severity management. OBJECTIVE: To assess the benefit of a light balm containing vitamin E, tocopherol and glycerine and enriched with Aqua posae filiformis and microresyl (Emollient+) in subjects with mild AD over a period of 168 days. MATERIALS AND METHODS: For this open-label study, subjects above 3 years of age with mild and stable AD for at least 6 months before inclusion and with a SCORAD score of <25 were eligible. Assessments took place at baseline, D14, D28, D84 and D168, and included SCORAD, flare frequency, severity of clinical signs and symptoms, skin hydration status using a Corneometer and local tolerance. QoL was assessed using the DLQI or CDLQI questionnaire. Subjects used Emollient+ at least once daily. RESULTS: Overall, 56 subjects were included in this study. The mean age was 25.0±20.0 years (45% children); 69.6% were females. Except for erythema in the paediatric population, all clinical parameters had significantly (all p < 0.05) improved at D28. At D168, SCORAD, signs and symptoms had significantly (all p < 0.05) improved in the global, adult and paediatric population at D168 compared to baseline. So did flares, skin hydration and QoL. The regimen was very well tolerated. CONCLUSION: Emollient+ is highly beneficial and well tolerated in mild AD with early benefits in improving AD signs and symptoms and skin hydration as well as the QoL of subjects as soon as D28. CLINICALTRIALSGOV IDENTIFIER: NCT05783453.