The main study objective is to determine the time to, as well as number of exacerbations of atopic dermatitis in the study period between the study groups A and B. The secondary objectives are the differences in transepidermal water loss and Quality…
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main endpoint will be the number of, and time to, exacerbation of atopic
dermatitis. To assess a profile of which patients are better to treatable with
topical vitamin D, filaggrin mutation and vitamin D levels at the start of
treatment will be assessed.
Secondary outcome
The quality of life in patients using the different treatment and the
difference of transepidermal water loss between the two treatment groups.
Background summary
Atopic dermatitis (AD) is a common relapsing chronic skin disease. One of the
contributing etiologic mechanisms is an impaired epidermal barrier. The
epidermis in AD has a higher proliferation rate, and less differentiation than
skin of healthy controls. A loss-of-function mutation in FLG is associated with
AD. This gene encodes for filaggrin, an important component of the epidermal
barrier. AD is treated with topical corticosteroids that have several
side-effects. Finding new treatment options is therefore needed. Vitamin D has
proven to have beneficial effects on AD. Topical vitamin D3 analogues show an
improvement of the epidermal barrier, with little to no side-effects, but have
never been examined for the effects on AD. Therefore, we will examine the
effects of topical vitamin D on AD. The expectation is that administering these
ointments to patients with AD will reduce the symptoms.
Study objective
The main study objective is to determine the time to, as well as number of
exacerbations of atopic dermatitis in the study period between the study groups
A and B. The secondary objectives are the differences in transepidermal water
loss and Quality of Life between the study groups.
Study design
Single blind, randomised control, intervention study
Intervention
Patients in the first group will be treated with the golden standard for atopic
eczema: corticosteroid ointment; specifically mometason ointment. The second
group of patients will be treated with vitamin D ointment as active treatment.
Both groups are allowed to use several kinds of emolliens as maintenance
treatment.
Study burden and risks
Burden and risk associated with participation are low. Subjects will be asked
to visit the out-patient clinic 3 times, in 4 months. The overall data is
acquired by physical examination, non-invasive measurement (quality of live
questionnaires and TEWL-measurement) and 2 venapunctures (for assessment of
their vitamin D level). Patients will be asked for permission to check their
DNA for a filaggrin mutation; this can be obtained with a cheek swab. Patients
are free to refuse this test. The investigational drug, calcitriol ointment,
has already been registered for use in another skin disease and has been shown
to have little to no side effects.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
Age 18 years or older. Mild to moderate atopic dermatitis, with a SCORAD score between 15 and 40. Informed consent.
Exclusion criteria
- Oral use of prescribed vitamin D or calcium supplements.
-Pregnancy
-Lactating women
-Patients who receive specialized treatment for disorders in calcium homeostasis and/or liver and kidney diseases.
-Inflammatory skin diseases unrelated to atopic dermatitis, except acneiform eruption.
-Sunny holiday during the previous 6 weeks
-Use of sunbeds or UV-therapy.
-Allergy/intolerance for ingredients used in the study medications.
-Previously documented non-compliance.
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2011-005874-53-NL |
| CCMO | NL38530.029.11 |