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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-005232-81-NL

Enrollment

Registered

2008-01-08

Start date

2008-09-11

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

atopic dermatitis MedDRA version: 9.1 Level: LLT Classification code 10003639 Term: Atopic dermatitis

Interventions

Trade Name: Elocon cream Product Name: Elocon Pharmaceutical Form: Cream Pharmaceutical form of the placebo: Cream Route of administration of the placebo: Cutaneous use Trade Name: vasline 20% cetoma

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: • Known pre-existing, serious underlying disease • (secondary) infected eczema: o 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. o Eczema 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

Design outcomes

Primary

Measure	Time frame
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).	—

Measure

Time frame

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).

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Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026