Efficacy and tolerability of captopril ointment 0,1%, 0,3% and 1,0% in psoriasis vulgaris. A randomised, double-blind, placebocontrolled, doseescalating, intra-individual clinical study

• Conditions: Patients with psoriasis vulgaris; MedDRA version: 9.1Level: LLTClassification code 10050576Term: Psoriasis vulgaris

• Registration Number: EUCTR2008-006004-36-DK
• Lead Sponsor: ACE ApS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11-04
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients with psoriasis vulgaris
Age 18-80 (both included)
White (caucasian)
Normal weight
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Active psoriasis on test plaques reguiring dermatological treatment
Other skin disease (e.g. contact allegy, atopic dermatitis, urticaria)
Dermatological lighttreatment or use of solarium 4 weeks prior to the trial.
Start of systemic treatment prior to study start which can influence on the test plaques. Stabil systemic treatment started 4 month prior to study start are allowed as well as local treatment on other plaques than test plaques during the trial.
Known hypersensitivity to any constituents or active ingredients in the amounts present in the trial medication.
Known coronary heart disease.
Alcohol abuse or other type of abuse or dependency.
Pregnancy.
Participation in a clinical trial within 30 days prior to inclusion in this trial.
Lack of use of safe anticontraception.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy, tolerability and safety of captopril ointment (0,1 %, 0,3 % and 1,0%) versus placebo after dermal application once daily in 6+6 (in total 12) weeks in subjects of both sexes with psoriasis vulgaris.;Secondary Objective: none;Primary end point(s): Objective clinical assessment of psoriasis with special assessment of redness, lichenisation, scale and assessment of the treated area.