An exploratory, open-label, intra-individual,active- controlled study comparing the efficacy and safety of Betesil versus Daivobet for the treatment of chronic plaque psoriasis

• Conditions: Chronic plaque psoriasis; MedDRA version: 9.1Level: LLTClassification code 10037153Term: Psoriasis

• Registration Number: EUCTR2008-005518-29-FR
• Lead Sponsor: aboratoires GENEVRIER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-21
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

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

Inclusion Criteria

Male outpatient aged = 18
With diagnosis of mild to moderate (4=TSS=8 and PGA score = 2 or 3), stable, chronic plaque psoriasis, for at least 12 months
With chronic plaque psoriasis located on both knees and/or both elbows
Involving less than 10% of the body surface area (BSA). 1 hand represents approximately 1% of total body surface area.
Psoriasis not requiring systemic treatment
With at least 2 bilateral plaques in extensory part of limbs (knees and/or elbows) > 10 cm² and < 150 cm² each
With target plaques of equivalent surface areas ± 10%

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

One of the clinical signs or symptoms having a score of 0
One of the clinical signs or symptoms having a score of 3
Subject having guttate, pustular or other non-plaque form of psoriasis
Subject only presenting with lesions on the scalp, face or intertriginous areas, not suitable for treatment with a topical adhesive plaster
Subject having used topical antipsoriatic treatments within 2 weeks prior to inclusion Or having received topical retinoids for psoriasis within 4 weeks prior to inclusion Or having received any systemic antipsoriatic therapy (including intralesional corticosteroid, UVB programs or UVA/psoralen programs) within 4 weeks prior to inclusion Or having used any bland emollient on areas to be treated within 48 hours prior to inclusion
Subject with other dermatological conditions that could interfere with the assessment of the psoriatic lesions
Subject suffering from severe systemic diseases
Subject with severe cardiac, renal or hepatic impairment
Subject with any underlying disease or medication that severely compromise the patient’s immune system
Patient suffering from a psychiatric disorder not treated

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare efficacy of Betesil® versus Daivobet® for the treatment of mil to moderate chronic plaque psoriasis.;Secondary Objective: to assess the safety of Betesil®;Primary end point(s): Total Severity Score (TSS) after 4 weeks of treatment.