|- candidate number||2145|
|- NTR Number||NTR715|
|- Date ISRCTN created||26-sep-2006|
|- date ISRCTN requested||13-sep-2006|
|- Date Registered NTR||23-jun-2006|
|- Secondary IDs||N/A |
|- Public Title||Study of the efficacy of topically applied cyclosporinsolution on psoriatic nails.|
|- Scientific Title||Study of the efficacy of topically applied cyclosporinsolution on psoriatic nails.|
|- Healt Condition(s) or Problem(s) studied||Psoriatic nails|
|- 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 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.
|- Exclusion criteria||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;
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jul-2006|
|- planned closingdate||1-jul-2006|
|- Target number of participants||40|
|- Interventions||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.
|- Primary outcome||NAPSI scores.|
|- Secondary outcome||Prevention? Does the NAPSI correlate with patientsatisfaction?|
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||MD. Annik Rengen, van|
|- CONTACT for SCIENTIFIC QUERIES||MD. Annik Rengen, van|
|- Sponsor/Initiator ||Erasmus Medical Center, Rotterdam|
(Source(s) of Monetary or Material Support)
|Novartis Pharma B.V.|
|- Brief summary||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.
|- Main changes (audit trail)|
|- RECORD||23-jun-2006 - 26-nov-2008|