Condition category
Skin and Connective Tissue Diseases
Date applied
28/12/2006
Date assigned
28/12/2006
Last edited
15/01/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.amc.uva.nl/#http://www.amc.uva.nl/

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

Publication citations

Additional files

Editorial Notes