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

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.

The primary objective of this study is to compare the efficacy of wet wrap
therapy with diluted corticosteroids versus wet wrap therapy with emollients.
The secondary objective is to develop an effective and objective value for
monitoring the severity of atopic dermatitis. Furthermore, quality of life and
patient-oriented eczema score will be measured during the therapy and safety of
the therapies will be evaluated.

A prospective, double-blind, randomised, multi center intervention study.

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.

Currently, wet wrap treatment with diluted corticosteroid cream or emollients
is indicated for all children with severe atopic dermatitis (objective SCORAD
>=40). Therefore, regular treatment does not differ from the treatment in this
study. Possible risks of regular wet-wrap treatment that, understandably, also
apply to this study are: feelings of discomfort and quivering due to the wet
wraps, folliculitis and secondary infection of the eczema. Possible risks of
the use of diluted corticosteroid creams in general are local effects on the
skin such as atrophy, couperose and hypertrichosis and systemic effects such as
adrenal suppression, weight gain and growth retardation. However, these risks
are minimal due to the fact that we use diluted corticosteroids. Moreover, we
will strictly monitor blood cortisol levels and height and weight. The number
of visits to the outpatient clinics during this study is the same as during
regular treatment with wet wraps. During the study period of 4 weeks, patients
will visit the outpatient clinic 5 times for clinical and laboratory
evaluation. Blood sampling will be done at 4 of these visits, which does not
differ from the regular treatment. The only difference with regular treatment
is that two extra blood containers must be taken during standard blood sampling
for marker evaluation (TARC MDC, sE-selectine CTACK sICAM RANTES). In addition,
the parents have to fill in a quality of life questionnaire and
patient-oriented eczema score questionnaire at the beginning and end of the
study. There are no extra benefits for participating to this study, except a
very intensive explanation and education.