No registrations found.
ID
Source
Brief title
Health condition
Atopic dermatitis
Sponsors and support
Intervention
Outcome measures
Primary outcome
Changed 22-may-2015:
1) Change in modified SCORAD in three and six weeks
Secondary outcome
- The amount of used cream/ointments (per day and total)
- Change in cytokine levels, lipid profile, Trans epidermal water loss and PH after the different treatments.
- presence of mutations on the Fillagrin-gene
Background summary
NA
Study objective
Dermalex eczema cream will decrease symptoms of atopic dermatitis significantly and will be superior to Unguentum leniens and Hydrocortison when used for a 6 week period
Study design
week 0, week 3, week 6
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.
K0-116
Meibergdreef 9
S.A. Koppes
Amsterdam 1105 AZ
The Netherlands
020 5665326
s.a.koppes@amc.nl
K0-116
Meibergdreef 9
S.A. Koppes
Amsterdam 1105 AZ
The Netherlands
020 5665326
s.a.koppes@amc.nl
Inclusion criteria
- Clinically diagnosed atopic dermatitis
- Mild to moderate atopic dermatitis, according to total SCORAD score (score <25 and <50 respectively)
- 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
IPD sharing statement
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 |
|---|---|
| NTR-new | NL4321 |
| NTR-old | NTR4541 |
| Other | METC AMC : 2014_090 |