The primary objective of this study is to compare the therapeutic effect on atopic dermatitis of a skin barrier repair cream (Dermalex eczema) in contrast to a standard used emollient (unguentum leniens FNA) and a dermatocorticoid (hydrocortisone)…
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The duration in days of used ointments until AD symptoms have improved, defined
as a decrease in SCORAD-score of 5 points
Secondary outcome
- The amount of used cream/ointments (per day and total)
- Change in cytokine levels, lipid profile, Trans epidermal water loss,
erythema and PH after the different treatments.
- presence of mutations on the Fillagrin-gene
Background summary
Atopic eczema ( AD) is a chronic and relapsing inflammatory skin disorder with
a wide spectrum of clinical presentations and combinations of symptoms. It
affects up to 20 percent of children and 2-10 percent of adults and often
predates the development of allergic airway diseases like rhinitis and asthma.
Skin barrier dysfunction, which can be inherited or acquired, is a major
hallmark of AD. A defective skin barrier in AD exists even in nonlesional skin
Current treatment of AD is the administration of topical corticosteroids or
immunosuppressive ointments to counter the immunological reaction and to
control flares. However, prolonged use of these treatments can induce
side-effects on the long-term, stressing the need to develop new treatment
applications.
The occlusive effect of emollients are temporary and do not actively improve
the skin barrier function. The investigated skin barrier repair cream (Dermalex
Eczema) contains magnesium salt and ceramides, both known to stimulate the
synthesis of stratum corneum lipids which are the principal barrier of the skin.
The aim of this study is to investigate the efficacy of Dermalex eczema cream
to a class 1 dermatocorticosteroid (hydrocortisone) en a frequently used
emollient (koelzalf)
immune response.
Study objective
The primary objective of this study is to compare the therapeutic effect on
atopic dermatitis of a skin barrier repair cream (Dermalex eczema) in contrast
to a standard used emollient (unguentum leniens FNA) and a dermatocorticoid
(hydrocortisone) assessed by clinical evaluation and biophysical parameters.
Study design
This is a multi-center, randomized, intra-individual comparison (right/left)
intervention study
Intervention
Patients are instructed to apply Dermalex eczema cream, a standard emollient or
a dermatocorticosetroid on one side of the body on atopic dermatitis lesions at
least twice a day. The opposite side will be topically treated with another of
the three creams twice a day. The patients will be randomized in three groups:
Dermalex eczema versus unguentum leniens, Dermalex eczema versus hydrocortisone
and unguentum leniens versus hydrocortison. Within the groups the creams will
be assigned right or left in a randomized order.
Study burden and risks
Negligible risk. The possibility of a (mild) Allergic reactions to ingredient
can not be ruled out but the risk is not increased compared to other
over-the-counter products.
meibergdreef 9
Amsterdam 1105
NL
meibergdreef 9
Amsterdam 1105
NL
Listed location countries
Age
Inclusion criteria
Clinically diagnosed atopic dermatitis;- Mild to moderate atopic dermatitis, according to total SCORAD score (score <25) ;- Age between 18 and 70 years;- Written informed consent ;- At least two symmetrical (i.e. left and right side of the body) skin sites with comparable AD severity (Measured in SCORAD-score)
Exclusion criteria
Extensive UV exposure in the last 14 days before study and/or expected during the study. ;- Other skin disease other than AD.;- Use of antibiotics prior to (4 weeks) the study and/or expected use during the study.;- Use of systemic suppressing drugs (e.g. prednisone, methothrexate) prior to (4 weeks) the study and/or expected use during the study;-Severe disorders within the last 6 months before study (e.g. cancer, acute cardiac or circularity disorders, HIV, infectious hepatitis);- Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements.
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 | EUCTR2014-001179-30-NL |
| CCMO | NL48640.018.14 |