|- candidate number||3105|
|- NTR Number||NTR1246|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||6-mrt-2008|
|- Secondary IDs||2008-077 MEC|
|- Public Title||Wet-wrap treatment in children with atopic dermatitis using the wet-wrap method with diluted corticosteroids versus emollients
|- Scientific Title||Wet-wrap treatment in children with atopic dermatitis using the wet-wrap method with diluted corticosteroids versus emollients
|- ACRONYM||Wet-wrap study in atopic dermatitis|
|- hypothesis||Wet-wrap treatment with diluted corticosteroids is more effective than wet-wrap treatment with emollients only|
|- Healt Condition(s) or Problem(s) studied||Emollients, Atopic dermatitis , Wet-wrap therapy, Constitutional eczema, Atopic eczema|
|- Inclusion criteria||1. Age 6 months - 6 years at inclusion |
2. Diagnosis of atopic dermatitis with an objective SCORAD > 40
3. Parent/legal guardian willing to comply with the protocol
4. Written, dated consent for subject to participate
|- Exclusion criteria||1. Known pre-existing, serious underlying disease |
2. (Secondary) infected eczema:
- In case of overt impetiginisation, wet wrapping should be delayed until 48-72 hours after commencing antibiotics and confirmation of appropriate treatment by skin swab results
- Eczema herpeticum is an absolute contraindication for the use of wet dressings
3. Signs and symptoms of systemic infection (such as fever, defined as a temperature equivalent to a rectal temperature greater than 38.3ºC)
4. Problems in the hypothalamus-pituitary-adrenal (HPA) axis
5. Systemic corticosteroid therapy
6. Severe growth retardation
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mei-2008|
|- planned closingdate||1-mei-2009|
|- Target number of participants||50|
|- Interventions||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).|
|- Primary outcome||The main endpoint concerns the comparison of the decrease of the objective SCORAD between the two groups for the various time points (=comparison of efficacy of the two therapies). |
|- Secondary outcome||One secondary endpoint is the change of serum markers levels at various time points in the two groups and the correlation of the serum markers levels to the objective SCORAD (=development of an effective and objective value for monitoring the severity of AD)
Another secondary endpoint is change in quality of life-score at the beginning and the end of the study in the two groups and the correlation of the quality of life score to the objective SCORAD and the serum markers.
|- Timepoints||Day 1, 4, 7, 14, 28.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Prof. Dr. Arnold P. Oranje|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. Arnold P. Oranje|
|- Sponsor/Initiator ||Havenziekenhuis Rotterdam|
(Source(s) of Monetary or Material Support)
|- Brief summary||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.
|- Main changes (audit trail)|
|- RECORD||6-mrt-2008 - 3-apr-2008|