Study of the efficacy of topically applied cyclosporin solution on psoriatic nails

ISRCTN	ISRCTN47031769
DOI	https://doi.org/10.1186/ISRCTN47031769
Protocol serial number	N/A
Sponsor	Erasmus Medical Center (The Netherlands)
Funder	Novartis Pharma B.V. (The Netherlands)

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

Dr Annik van Rengen
Scientific

Postbus 2040
Rotterdam
3000 CA
Netherlands

Phone	+31 (0)10 4634569
Email	a.vanrengen@erasmusmc.nl

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Cyclosporin
Primary outcome measure(s)	Nail Psoriasis Severity Index (NAPSI) scores.
Key secondary outcome measure(s)	1. Prevention 2. Does the NAPSI correlate with patient satisfaction
Completion date	01/07/2006

Participant type(s)	Patient
Age group	Not Specified
Sex	All
Target sample size at registration	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

Postbus 2040

Rotterdam
3000 CA
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan