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
ID
Bron
Verkorte titel
Aandoening
Atopic dermatitis
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Changed 22-may-2015:
1) Change in modified SCORAD in three and six weeks
Achtergrond van het onderzoek
NA
Doel van het onderzoek
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
Onderzoeksopzet
week 0, week 3, week 6
Onderzoeksproduct en/of interventie
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.
Publiek
K0-116
Meibergdreef 9
S.A. Koppes
Amsterdam 1105 AZ
The Netherlands
020 5665326
s.a.koppes@amc.nl
Wetenschappelijk
K0-116
Meibergdreef 9
S.A. Koppes
Amsterdam 1105 AZ
The Netherlands
020 5665326
s.a.koppes@amc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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)
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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.
Opzet
Deelname
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Opgevolgd door onderstaande (mogelijk meer actuele) registratie
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Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4321 |
| NTR-old | NTR4541 |
| Ander register | METC AMC : 2014_090 |