Efficacy of a novel emollient plus cream in atopic dermatitis: a randomised, vehicle-controlled, double-blind study

Efficacy of a novel emollient plus cream in atopic dermatitis: a randomised, vehicle-controlled, double-blind study 20 February 2019

Adele Sparavigna, Beatrice Tenconi, Laura La Penna

JOURNAL of PLASTIC and PATHOLOGY DERMATOLOGY vol. 15 – n. 2 – 2019

Background: Emollients comprising a variety of active ingredients to target atopic dermatitis (AD) pathophysiology have been developed. Objectives: To evaluate the efficacy of a novel emollient plus cream (EC; Dermoflan®) compared with vehicle for reducing the signs and symptoms of mild AD in adults.

Methods: Single-centre, randomised, double-blind study conducted in patients with mild AD. EC and vehicle were applied twice a day for 28 days, with a mild massage as per investigator instruction. The primary objective of the study was to compare the clinical efficacy of EC and vehicle on general pruritus. Secondary objectives included the effect of EC and vehicle on skin hydration, barrier function and desquamation, as well as tolerability and cosmetic acceptability. Efficacy parameters were assessed at baseline (T0), and after 14 days (T14d) and 28 days (T28d) of treatment.

Results: Fifty-eight forearms were treated with EC and 39 forearms were treated with vehicle. For patients treated with EC, there was a significant reduction of pruritus compared with baseline (T14d: 53%, p<0.05; T28d: 89%, p<0.05) and compared with vehicle (T14d: 53% vs 23%, p<0.05; T28d: 89% vs 60%, p<0.05). Improvement from baseline was also reported in patients treated with EC across all other parameters (skin hydration, barrier function and skin desquamation) at both timepoints (T14d and T28d). No adverse events were reported, and the majority of patients rated both products as good or excellent.Conclusions: These findings support the use of this novel EC as part of the treatment of patients with AD.