Excimer laser versus clobetasone propionate in prurigo form of atopic dermatitis
| ISRCTN | ISRCTN38773821 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN38773821 |
| Secondary identifying numbers | NL785, NTR797 |
- Submission date
- 28/12/2006
- Registration date
- 28/12/2006
- Last edited
- 14/01/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr E E A Brenninkmeijer
Scientific
Scientific
Academic Medical Center Amsterdam
Department of Dermatology, A0-223
P.O. Box 22660
Amsterdam
1105 AZ
Netherlands
| Phone | +31(0)20 566 2581 |
|---|---|
| E.E.Brenninkmeijer@amc.uva.nl |
Study information
| Study design | Randomised, controlled, parallel group, single blind, trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Excimer laser versus clobetasone propionate in prurigo form of atopic dermatitis |
| Study objectives | 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(s) | Approval recieved from the Medical Ethical Committee (Medisch Ethische Commissie) on the 19th October 2006 (ref: MEC 06/239). |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Clobetasol propionate |
| Primary outcome measure | 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 study start date | 01/11/2006 |
| Completion date | 01/08/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | 20 |
| Total final enrolment | 13 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/11/2006 |
| Date of final enrolment | 01/08/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Center Amsterdam
Amsterdam
1105 AZ
Netherlands
1105 AZ
Netherlands
Sponsor information
Academic Medical Center (AMC) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Dermatology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
| Website | http://www.amc.uva.nl/#http://www.amc.uva.nl/ |
|---|---|
"ROR" |
https://ror.org/03t4gr691 |
Funders
Funder type
Hospital/treatment centre
Academic Medical Center (AMC) (The Netherlands)
Private sector organisation / Universities (academic only)
Private sector organisation / Universities (academic only)
- Alternative name(s)
- Academic Medical Center, AMC
- Location
- Netherlands
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2010 | 14/01/2021 | Yes | No |
Editorial Notes
14/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
3. The NTR numbers have been added.
