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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR797 |
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Date of registration:
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19/09/2006 |
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Primary sponsor: |
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Public title:
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Excimer laser versus clobetason propionaat in prurigo form of atopic dermatitis.
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Scientific title:
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Excimer laser versus clobetason propionaat in prurigo form of atopic dermatitis. - N/A |
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Date of first enrolment:
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1/11/2006 |
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Target sample size:
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20 |
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Recruitment status: |
complete |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=797 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: Single; Control: Active; Group: Parallel; Type: 2 or more arms, randomized
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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E.E.A.
Brenninkmeijer |
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Address:
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Academic Medical Center Amsterdam (AMC)
Department of Dermatology, A0-223
P.O. Box 22660, Meibergdreef 9
1100 DD
Amsterdam
The Netherlands |
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Telephone:
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+31(0)20 5662581 |
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Email:
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E.E.Brenninkmeijer@amc.uva.nl |
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Affiliation:
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Name:
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E.E.A.
Brenninkmeijer |
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Address:
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Academic Medical Center Amsterdam (AMC)
Department of Dermatology, A0-223
P.O. Box 22660, Meibergdreef 9
1100 DD
Amsterdam
The Netherlands |
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Telephone:
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+31(0)20 5662581 |
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Email:
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E.E.Brenninkmeijer@amc.uva.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Adult patients (>18 years old);
2. Prurigo form of atopic dermatitisbased on:
2.1 Hanifin and Rajka criteria fullfilled;
2.2 Presence of allergen specific IgE;
2.3 Lasting for at least 6 months;
2.4 Refractory to the standard therapy;
2.5 At least 4 symmetrical nodules;
3. Upper or lower extremities affected;
4. Written informed consent provided.
Exclusion criteria: 1. Patients unable to comply with the requirements of the study;
2. Female patients who are pregnant or breastfeeding;
3. Patients treated with sedating antihistamines within 24hrs before start of study treatment;
4. Patients treated with topical steroids within one week before start of study treatment;
5. Patients treated with phototherapy or PUVA within one week before start of study treatment;
6. Patients treated with systemic therapy that might have an effect on the prurigo form of AD within 4 weeks before start of study treatment;
7. Patients with hypersensitivity to the study treatment or sunlight;
8. Patients receiving drugs known to cause photosensitivity and/or photo toxicity;
9. Patients with any other interfering skin diseases, which jeopardize the study.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Atopic dermatitis
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Intervention(s)
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All patients will be randomized to a within-patient left-right comparison study of excimer laser versus topical clobetason propionaat. Treatment with the ecximer laser will be performed twice a week, during a treatment period of 10 weeks. Clobetason propionaat will be applied by the patients themselves once a day , according standardised instructions, during a treartment period of 10 weeks.
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Primary Outcome(s)
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Clinical responses will be evaluated using Physician assessment of individual signs (number of nodules, elevation of nodules, excoriation, erythema and pruritus).
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Secondary Outcome(s)
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Photographic documentation, Physician Global assessment (PGA) and Patient Global Assessment (PaGA) will be evaluated. Besides the clinical responses, the patient and physician satisfaction/preference and duration of remission will be evaluated.
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Secondary ID(s)
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ISRCTN38773821
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N/A
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Source(s) of Monetary Support
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Academic Medical Center (AMC), Department of Dermatology
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