To compare the clinical outcome of daily showering followed by immediate application of emollient to once weekly showering followed by immediate application of emollient, in children with mild to moderate AD. The primary outcome parameter will be…
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
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 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).
Background 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 (Richtlijn Constitutioneel
Eczeem) 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.
Study objective
To compare the clinical outcome of daily showering followed by immediate
application of emollient to once weekly showering followed by immediate
application of emollient, in children with mild to moderate AD. The primary
outcome parameter will be the objective SCORing Atopic Dermatitis (SCORAD).
Study design
This will be a randomized, controlled, observer blinded, superiority clinical
trial with two parallel groups.
Intervention
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.
Study burden and risks
Participation in this study implies no health risks and little discomfort.
Patients are allowed to continue medical care (except for tar ointments) for
their AD. In current practice, patients exhibit varying bathing habits, ranging
from once a month to twice daily. The 2 chosen shower regimens are therefore
suitable with examples from common practice. The tape stripping is painless and
without any side effects. TEWL and skin capacitance measurements are
non-invasive and without any side effects. There is no direct benefit for the
participants.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Male or female patients with atopic dermatitis (AD) according to the UK working party criteria
Age 4-12 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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL52319.018.15 |