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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-006004-36-DK

Enrollment

Registered

2008-11-04

Start date

2008-12-16

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with psoriasis vulgaris MedDRA version: 9.1 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris

Interventions

Product Name: Captopril ointment Product Code: na Pharmaceutical Form: Ointment INN or Proposed INN: Captopril Concentration unit: % percent Concentration type: equal Concentration number: 1,0, 0,3, 0

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Denmark

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026