N/A
ID
Bron
Verkorte titel
Aandoening
Psoriasis of the vingernails.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
NAPSI scores.
Achtergrond van het onderzoek
The aim of the study is to establish and evaluate the affectivity of topical application of cyclosporine in psoriasis of the fingernails.
Patients with psoriasis of fingernails presenting at the outpatient department of Dermatology Erasmus MC. The patients receive 2 identical bottles, one for the left and one for the right hand to take home. One bottle contains cyclosporine solution (Neoral drink) and the other contains
maize oil. The patients apply the solution to the affected nails and nail wall with an applicator (small brush) twice a day. The duration of the treatment is till complete cure or for a maximum of 16 weeks. The follow-up is for 12 weeks after stopping the treatment.
The nail abnormality is photographed before the start of the treatment.
The nail psoriasis severity index (NAPSI) is calculated for the affected nails on each visit. This will also serve for further follow-up.
Doel van het onderzoek
N/A
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
On left and right vingernails either placebo, either 100mg/ml ciclosporin application, twice daily.
The duration of the treatment is till complete cure or for a maximum of 16 weeks.
Control group maximal 28 weeks.
Publiek
Dr. Molewaterplein 40,
P.O. Box 2040
Annik Rengen, van
Rotterdam 3000 CA
The Netherlands
+31 (0)10 4634569
a.vanrengen@erasmusmc.nl
Wetenschappelijk
Dr. Molewaterplein 40,
P.O. Box 2040
Annik Rengen, van
Rotterdam 3000 CA
The Netherlands
+31 (0)10 4634569
a.vanrengen@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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 8 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 2 affected nails on the left hand and the right hand, and the number of affected nails may differ by 1 nail at the maximum on the left hand compared with those on the right hand.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Systemic treatment with cyclosporine or a biological agent (efaluzimab, etanercept or related medication);
2. Change of oral medication 8 weeks before the start of the trial;
3. Pregnancy.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL705 |
| NTR-old | NTR715 |
| Ander register | : N/A |
| ISRCTN | ISRCTN47031769 |