Contact information
Type
Scientific
Primary contact
Dr Annik van Rengen
ORCID ID
Contact details
Postbus 2040
Rotterdam
3000 CA
Netherlands
+31 (0)10 4634569
a.vanrengen@erasmusmc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
The aim of the study is to establish and evaluate the affectivity of topical application of cyclosporin in psoriasis of the fingernails.
Ethics approval
Ethics approval received from the local medical ethics committee
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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 names
Cyclosporin
Primary outcome measures
Nail Psoriasis Severity Index (NAPSI) scores.
Secondary outcome measures
1. Prevention
2. Does the NAPSI correlate with patient satisfaction
Overall trial start date
01/07/2006
Overall trial end date
01/07/2006
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
40
Participant 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
Recruitment start date
01/07/2006
Recruitment end date
01/07/2006
Locations
Countries of recruitment
Netherlands
Trial participating centre
Postbus 2040
Rotterdam
3000 CA
Netherlands
Funders
Funder type
Industry
Funder name
Novartis Pharma B.V. (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary