search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


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


- candidate number3105
- NTR NumberNTR1246
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-mrt-2008
- Secondary IDs2008-077 MEC
- Public TitleWet-wrap treatment in children with atopic dermatitis using the wet-wrap method with diluted corticosteroids versus emollients
- Scientific TitleWet-wrap treatment in children with atopic dermatitis using the wet-wrap method with diluted corticosteroids versus emollients
- ACRONYMWet-wrap study in atopic dermatitis
- hypothesisWet-wrap treatment with diluted corticosteroids is more effective than wet-wrap treatment with emollients only
- Healt Condition(s) or Problem(s) studiedEmollients, Atopic dermatitis , Wet-wrap therapy, Constitutional eczema, Atopic eczema
- Inclusion criteria1. 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 criteria1. 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 38.3C)
4. Problems in the hypothalamus-pituitary-adrenal (HPA) axis
5. Systemic corticosteroid therapy
6. Severe growth retardation
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2008
- planned closingdate1-mei-2009
- Target number of participants50
- InterventionsWet-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 outcomeThe 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 outcomeOne 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.
- TimepointsDay 1, 4, 7, 14, 28.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESProf. Dr. Arnold P. Oranje
- CONTACT for SCIENTIFIC QUERIESProf. Dr. Arnold P. Oranje
- Sponsor/Initiator Havenziekenhuis Rotterdam
- Funding
(Source(s) of Monetary or Material Support)
Havenziekenhuis Rotterdam
- PublicationsN/A
- Brief summaryRationale: 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 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)
- RECORD6-mrt-2008 - 3-apr-2008


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl