Chronic plaque psoriasis MedDRA version: 9.1 Level: LLT Classification code 10037153 Term: Psoriasis
Conditions
Interventions
Trade Name: BETESIL
Product Name: BETESIL
Pharmaceutical Form: Medicated plaster
INN or Proposed INN: Bétaméthasone valerate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration
Sponsors
Laboratoires GENEVRIER
Eligibility
Sex/Gender
Male
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
France
Outcome results
None listed