Efficacy and tolerance assessment of a new type of dermocosmetic in infants and children with moderate atopic dermatitis.

ABSTRACT

BACKGROUND: Atopic dermatitis (AD) is an inflammatory and pruritic skin disorder. OBJECTIVES: To assess the efficacy and tolerance of a new emollient (SBT complex) in subjects with moderate AD. METHODS: Subjects received twice daily for 168 days (6 months) either SBT complex or emollient base adjunctively or alternately with topical corticosteroids or calcineurin inhibitors. Evolution of AD was assessed throughout the study using usual AD assessment criteria including SCORAD and PO-SCORAD. Quality of life was assessed at Day 0 and Day 168. RESULTS: At Day 168, a significant decrease with SBT complex was observed for the SCORAD and the PO-SCORAD scores (P < 0.05), the primary efficacy criteria. A total of 76% of SBT complex subjects did not relapse and time-to-relapse increased compared to the emollient base subjects. Intensity, dryness, and quality of life (P < 0.05) had improved in subjects using SBT complex. The product was well tolerated with less physical and functional signs in the SBT than in the emollient base group. CONCLUSION: The new emollient dermocosmetic SBT complex applied adjunctively or alternately with topical AD treatments significantly improved AD without any safety concerns. SBT complex may play an important role in the restoration of the natural skin barrier.