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WATER study

Daily vs. weekly showering in atopic dermatitis: a randomized controlled clinical trial.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON24085
Enrollment
46
Registered
2015-07-04
Start date
2015-07-08
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, water, showering, bathing, emollient. atopisch eczeem, constitutioneel eczeem, water, douchen, baden, emolliens

Interventions

Each patient is assigned a randomization number according to a computer generated randomization. Randomization will be performed with a 1:1 allocation. One group will shower once daily every day accor
the other group will shower once weekly according to a standard protocol for 4 weeks. All patients will use emollients daily and will be allowed to continue topical medication (except tar ointments) a

Sponsors

Academic Medical Center, Amsterdam, The Netherlands
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Male or female patients with AD according to the UK working party criteria Age 4 to 11 years Mild to moderate AD (objective SCORAD < 40) Having access to a shower Presence of 1 AD lesion and a part of non-lesional skin on preferably the ventral (fore) arm Written informed consent of both parents/ legal representative(s)

Exclusion criteria

Exclusion criteria: Active skin infection requiring antibiotic treatment Systemic immunomodulatory treatment (for AD or other diseases) Intolerance to Vaseline paraffin ANA Unwillingness to use Vaseline paraffin ANA as sole emollient Usage of tar ointments Usage of thin bleach baths Performance of water sports (swimming etc) more than once a week

Design outcomes

Primary

MeasureTime frame
Comparison of change in objective SCORAD from week 4 compared to week 0 between procedure groups.

Secondary

MeasureTime frame
Comparison of change in Eczema Area and Severity Index (EASI), quality of life, AD symptoms, transepidermal water loss, skin capacitance, natural moisturizing factors and skin lipids in tape strips at week 4 compared to week 0 between procedure groups. Used amounts of topical medication and Vaseline paraffin ANA and patient’s preference for once weekly vs daily showering at week 4 will be compared between procedure groups. The change in objective SCORAD from week 4 compared to week 0 will be compared between procedure groups, stratified by mild vs moderate AD, and stratified by light skin types (1, 2, 3) vs dark skin types (4, 5, 6).

Contacts

Public ContactM.A. Middelkamp Hup

Academic Medical Center - Dept. of Dermatology, A0-223

E: water@amc.uva.nlT: +31.20.566.2482

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)