Wet-wrap treatment in children with atopic dermatitis using the wet-wrap method with diluted corticosteroids versus emollients

Rationale: Throughout the world, wet wrap therapy is advocated by dermatologists for treatment of children with severe atopic dermatitis. However, there is no consensus regarding the best method for wet wrap therapy with respect to the ointment or cream to be used under the wet dressings.
Objective: The main objective of this study is to compare the efficacy of wet wrap therapy with diluted corticosteroids versus wet wrap therapy with emollients. The secondary objectives are to develop an effective and objective value for monitoring the severity of atopic dermatitis, to monitor quality of life during therapy and to evaluate the safety of both therapies.
Study design: A prospective, double-blind, randomised, multi center intervention study.
Study population: Children 6 months-6 years old with severe atopic dermatitis (objective SCORAD ¡Ý 40).
Intervention: Patients will be randomised over 2 groups: the first group receives therapy with diluted corticosteroid cream under wet wraps and the second group receives emollients under wet-wraps.
Main study endpoint: The main endpoint of the study is the comparison of the decrease of the objective SCORAD between the two groups for the various time points.

Wet-wrap treatment with diluted corticosteroids is more effective than wet-wrap treatment with emollients only

Day 1, 4, 7, 14, 28.

Wet-wrap therapy with diluted corticosteroid cream (mometason-furoaat with vaseline 20% cetomacrogolcream dilution 1:19 face and 1:3 body) vs. wet-wrap therapy with emollients (vaseline 20% cetomacrogolcream).