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.
ID
Bron
Verkorte titel
Aandoening
atopic dermatitis, atopic eczema, water, showering, bathing, emollient.
atopisch eczeem, constitutioneel eczeem, water, douchen, baden, emolliens
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Comparison of change in objective SCORAD from week 4 compared to week 0 between procedure groups.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
At the start (day 1) and the end (day 28) of the study
Onderzoeksproduct en/of interventie
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.
Publiek
M.A. Middelkamp Hup
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
T: +31.20.566.2482
E: water@amc.uva.nl
Wetenschappelijk
M.A. Middelkamp Hup
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
T: +31.20.566.2482
E: water@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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)
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL5163 |
NTR-old | NTR5303 |
Ander register | Medisch ethische commissie van het Academisch Medisch Centrum, Amsterdam : METC 2015_023 |