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

• Conditions: atopic dermatitis; MedDRA version: 9.1Level: LLTClassification code 10003639Term: Atopic dermatitis

• Registration Number: EUCTR2007-005232-81-NL
• Lead Sponsor: Havenziekenhuis/ErasmusMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01-08
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

•Age 6 months- 6 years at inclusion
•Diagnosis of atopic eczema with an objective SCORAD = 40
•Parent/legal guardian willing to comply with the protocol
•Written, dated consent for subject to participate

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Known pre-existing, serious underlying disease
•(secondary) infected eczema:
oIn 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.
oEczema herpeticum is an absolute contraindication for the use of wet dressings.
•Signs and symptoms of systemic infection (such as fever, defined as a temperature equivalent to a rectal temperature greater than 38.3ºC).
•Problems in the hypothalamus-pituitary-adrenal axis (HPA)
•Systemic corticosteroid therapy
•Severe growth retardation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main 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. ;Secondary Objective: The secondary objectives are to evaluate the value of several serum markers for objectively monitoring the severity of atopic dermatitis, to evaluate quelity of life and to evaluate the safety of both therapies. ;Primary end point(s): The main endpoint concerns the comparison between the two groups of the decrease of the objective SCORAD for the various time points (=comparison of efficacy of the two therapies).