Skip to content

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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON21806
Enrollment
50
Registered
2008-03-06
Start date
2008-05-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

atopic dermatitis atopic eczema wet-wrap therapy atopisch eczeem constitutioneel eczeem emollients

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% cetomacrog

Sponsors

Charlotte van Sassen, KinderHaven, Havenziekenhuis Rotterdam
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Contacts

Public ContactArnold P. Oranje

(Kinder)dermatologie Erasmus MC en KinderHaven, Rotterdam

a.p.oranje@erasmusmc.nl+31(010) 703 6656/6653/2697 of (010) 404 3700

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)