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Efficacy of Dermalex Eczema in atopic dermatitis patients


- candidate number17585
- NTR NumberNTR4541
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-apr-2014
- Secondary IDs2014_090 METC AMC
- Public TitleEfficacy of Dermalex Eczema in atopic dermatitis patients
- Scientific TitleEfficacy of a skin barrier repair cream (Dermalex Eczema) in atopic dermatitis patients
- ACRONYMEDA
- hypothesisDermalex 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
- Healt Condition(s) or Problem(s) studiedAtopic dermatitis
- 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.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 6-mei-2014
- planned closingdate6-mei-2015
- Target number of participants100
- InterventionsPatients 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.
- Primary outcomeThe 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 and PH after the different treatments.
- presence of mutations on the Fillagrin-gene
- Timepointsweek 0, week 3, week 6
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD S.A. Koppes
- CONTACT for SCIENTIFIC QUERIESMD S.A. Koppes
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- Publications
- Brief summary
- Main changes (audit trail)22-mei-2015: Change-EB

Primary outcome:
New: 1) Change in modified SCORAD in three and six weeks Old: The duration in days of used ointments until AD symptoms have improved, defined as a decrease in SCORAD-score of 5 points

Inclusion:
New: Mild to moderate atopic dermatitis, according to total SCORAD score (score <25 and <50 respectively )
- RECORD28-apr-2014 - 22-mei-2015


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