Contact information
Type
Scientific
Primary contact
Dr E E A Brenninkmeijer
ORCID ID
Contact details
Academic Medical Center Amsterdam
Department of Dermatology
A0-223
P.O. Box 22660
Amsterdam
1105 AZ
Netherlands
+31(0)20 566 2581
E.E.Brenninkmeijer@amc.uva.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
As Narrow Band UltraViolet B (NB-UVB) is known to be effective in Atopic Dermatitis (AD), the excimer laser appears to be a promising treatment for localised AD. We designed a randomised single blind within-patient controlled trial to investigate the efficacy of the excimer laser versus routine topical corticosteroid, clobetason propionate.
Ethics approval
Approval recieved from the Medical Ethical Committee (Medisch Ethische Commissie) on the 19th October 2006 (ref: MEC 06/239).
Study design
Randomised, controlled, parallel group, single blind, trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Atopic dermatitis
Intervention
All patients will be randomised to a within-patient left-right comparison study of excimer laser versus topical clobetason propionate. Treatment with the ecximer laser will be performed twice a week, during a treatment period of ten weeks. Clobetason propionate will be applied by the patients themselves once a day , according standardised instructions, during a treartment period of ten weeks.
Intervention type
Drug
Phase
Not Specified
Drug names
Clobetasol propionate
Primary outcome measures
Clinical responses will be evaluated using physician assessment of individual signs (number of nodules, elevation of nodules, excoriation, erythema and pruritus).
Secondary outcome measures
1. Photographic documentation
2. Physician Global Assessment (PGA)
3. Patient Global Assessment (PaGA)
4. Besides the clinical responses, the patient and physician satisfaction/preference and duration of remission will be evaluated.
Overall trial start date
01/11/2006
Overall trial end date
01/08/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Adult patients (over 18 years old)
2. Prurigo form of atopic dermatitisbased on:
a. Hanifin and Rajka criteria fullfilled
b. presence of allergen specific Immunoglobulin E (IgE)
c. lasting for at least six months
d. refractory to the standard therapy
e. at least four symmetrical nodules
3. Upper or lower extremities affected
4. Written informed consent provided
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
20
Participant 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 24 hours 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 Psoralen UltraViolet A (PUVA) therapy 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 four 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
Recruitment start date
01/11/2006
Recruitment end date
01/08/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
Academic Medical Center Amsterdam
Amsterdam
1105 AZ
Netherlands
Sponsor information
Organisation
Academic Medical Center (AMC) (The Netherlands)
Sponsor details
Department of Dermatology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Academic Medical Center (AMC) (The Netherlands)
Alternative name(s)
Academic Medical Center, AMC
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
Netherlands
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary