Study of the efficacy of topically applied cyclosporin solution on psoriatic nails
| ISRCTN | ISRCTN47031769 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47031769 |
| Secondary identifying numbers | N/A |
- Submission date
- 26/09/2006
- Registration date
- 26/09/2006
- Last edited
- 10/03/2008
- 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
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Annik van Rengen
Scientific
Scientific
Postbus 2040
Rotterdam
3000 CA
Netherlands
| Phone | +31 (0)10 4634569 |
|---|---|
| a.vanrengen@erasmusmc.nl |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | The aim of the study is to establish and evaluate the affectivity of topical application of cyclosporin in psoriasis of the fingernails. |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Psoriatic nails |
| Intervention | On left and right fingernails either placebo, or 100 mg/ml cyclosporin application, twice daily. The duration of the treatment is till complete cure or for a maximum of 16 weeks. Control group maximal 28 weeks |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Cyclosporin |
| Primary outcome measure | Nail Psoriasis Severity Index (NAPSI) scores. |
| Secondary outcome measures | 1. Prevention 2. Does the NAPSI correlate with patient satisfaction |
| Overall study start date | 01/07/2006 |
| Completion date | 01/07/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | 40 |
| Key inclusion criteria | 1. Clinical diagnosis of psoriasis of fingernails in both hands 2. In cases of oral treatment with methotrexate, prednisone or fumarates, the dose of medication before the start has to be constant for eight weeks and it may be reasonably expected that the dose shall not be altered during the treatment phase of the study 3. A minimum of at least two affected nails on the left hand and the right hand, and the number of affected nails may differ by one nail at the maximum on the left hand compared with those on the right hand |
| Key exclusion criteria | 1. Systemic treatment with cyclosporine or a biological agent (efaluzimab, etanercept or related medication) 2. Change of oral medication eight weeks before the start of the trial 3. Pregnancy |
| Date of first enrolment | 01/07/2006 |
| Date of final enrolment | 01/07/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Postbus 2040
Rotterdam
3000 CA
Netherlands
3000 CA
Netherlands
Sponsor information
Erasmus Medical Center (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
"ROR" |
https://ror.org/018906e22 |
|---|
Funders
Funder type
Industry
Novartis Pharma B.V. (The Netherlands)
No information available
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 |
