Condition category
Skin and Connective Tissue Diseases
Date applied
26/09/2006
Date assigned
26/09/2006
Last edited
10/03/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

Erasmus Medical Center (The Netherlands)

Sponsor details

P.O. Box 2040
Rotterdam
3000 CA
Netherlands

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes