Efficacy and tolerance of dermocosmetic gel-cream combined and in relay with topical corticosteroids treatment in atopic dermatitis children

Emollients are recommended for patients suffering from atopic dermatitis (AD). Since AD is often associated with wintertime, emollients are usually balms with rich texture. But atopic patients use this kind of product all year long. And some countries, experience basically two seasons included the monsoon and the dry season when AD can be aggravated [1]. Therefore, the aim of the study is to evaluate in different countries of Latin America, the efficacy and tolerance of an AD-specific dermo-cosmetic product with an adapted a gel-cream texture.

An open multi-centric clinical study, including 5 visits (D-15 or -7, D0, D28, D56 and D84 ±2 days) was performed in Argentina, Colombia, and Peru from August 2021 to March 2022. 56 children from 9 months to 12-year-old (mean age 5.3y) with mild to moderate atopic dermatitis were included. They presented AD history of 9 months to 2 years and were starting at the inclusion time a topical corticosteroid treatment due to a flare-up. The dermo-cosmetic gel-cream was applied twice daily on the face and body in association with topical corticosteroids treatment and then since D0 in relay to treatment for 3 months. The SCORAD, the cutaneous dryness (4-point scale), and the pruritus (11-point Numerical Rating Scale) were evaluated by the investigator at 7 to 15 days before D0, D0 and D28, D56 and D84. The relapse was assessed by reporting the number and the duration of relapses at D28, D56 and D84. Moreover, the subject or parents evaluated at each study visit the quality of life using the Infant Dermatitis Quality of Life (IDQoL) for children from 6 months to 4 years, the impact of pruritus on the sleep quality, and at D84 the skin dryness global efficacy (5-point scale) and the subjective efficacy (4-point scale) for all the included children. Furthermore, the potential adverse events were reported during each study visit by the investigator.

At D0, the SCORAD was significantly reduced by -62% compared to D-15, after the period of topical corticosteroid application. And compared to D0, after the application the dermo-cosmetic gel-cream, the SCORAD mean decreased significantly by -28%, -41% and -52%, and the relapse by -29%, -23% and -16% at D28, D56 and D84, respectively. At D84, the skin dryness was reduced by -56% with an improvement or a disappearance reported by 99% of the subjects and 91% for the investigator. The pruritus was also decreased by - 52%, and the IDQoL score by -60% at D84 compared to D0. Moreover 90% of the subjects had a complete night improving significantly by -73% the number of awake at D84 vs. D0. Furthermore, the dermo-cosmetic gel-cream was well appreciated on the subjective efficacy assessment (Figure 1). During the study, no adverse event was reported, so the dermo-cosmetic gel-cream was very well tolerated by all the children.