|- candidate number||22414|
|- NTR Number||NTR5303|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||4-jul-2015|
|- Secondary IDs||METC 2015_023 Medisch ethische commissie van het Academisch Medisch Centrum, Amsterdam|
|- Public Title||WATER study|
|- Scientific Title||Daily vs. weekly showering in atopic dermatitis: a randomized controlled clinical trial.
|- ACRONYM||WATER study|
|- hypothesis||Daily showering followed by immediate application of emollient is better for the clinical outcome of mild to moderate AD in children, when compared to once weekly showering followed by immediate application of emollient.|
|- Healt Condition(s) or Problem(s) studied||Atopic eczema, Constitutional eczema, Emollients|
|- 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||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
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||8-jul-2015|
|- planned closingdate|
|- Target number of participants||46|
|- 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 according to a standard protocol for 4 weeks; 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) as prescribed by their dermatologist.|
Patienst will be evaluated at the start and end of the study. During these visits the severity of AD will be scored, 4 questionnaires on AD symptoms and quality of life will be obtained, non-invasive skin measurements of transepidermal water loss and skin capacitance will be performed, and tape strips will be obtainen. This interventions are painless. In week 2 of the study a telephone consultation will take place to discuss possible questions etc. the patients may have.
|- Primary outcome||Comparison of change in objective SCORAD from week 4 compared to week 0 between procedure groups.
|- Secondary outcome||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 patientís 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).
|- Timepoints||At the start (day 1) and the end (day 28) of the study|
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MD, PhD M.A. Middelkamp Hup|
|- CONTACT for SCIENTIFIC QUERIES||MD, PhD M.A. Middelkamp Hup|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|Academic Medical Center (AMC)|
|- Brief summary||Summary: Atopic dermatitis (AD) is a common disease in children. There is much uncertainty on how frequent children with AD should shower because of lack of scientific evidence. In the Dutch guidelines for AD no advice is given on this topic, because of lack of evidence. The European guidelines advice daily showering/bathing, but do this based on expert opinion due to lack of trials.The American guidelines conclude that randomized controlled trials to better determine optimal bathing techniques, including controlled studies on frequency, duration, and the effects of bathing and use of bath emollients are a significant gap in research in the management of AD.
Countries of recruitment: Patients will be recruited in The Netherlands.
|- Main changes (audit trail)|
|- RECORD||4-jul-2015 - 18-okt-2015|