chronic plaque psoriasis (psoriasis vulgaris) MedDRA version: 12.0 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris
Conditions
Interventions
Trade Name: Betesil® 2.250 medicated plaster
Pharmaceutical Form: Medicated plaster
INN or Proposed INN: Betamethasone Valerate
CAS Number: 2152-44-5
Concentration unit: mg milligram(s)
Concentration
Sponsors
IBSA, Institut Biochimique SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Out-patients of both gender; - Aged 18 years or more; - With diagnosis of mild-to-moderate (TSS = 4, as judged by the Investigator), stable, chronic plaque psoriasis, for at least 12 months; - Involving less than 10% of the body surface area (BSA) (1 hand representing approximately 1% of BSA) (i.e. mild-to-moderate psoriasis according to CHMP/EWP/2454/02corr19); - Not requiring systemic treatment; - With at least 2 bilateral plaques in extensory part of limbs, i.e knees and/or elbows, >10 cm2 and =65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Female subjects of childbearing potential (i.e., not status post hysterectomy or tubal ligation) not using an appropriate method of contraception according to the definition of Note 3 of ICH M3 Guideline1; - Pregnant or lactating women; - Subjects who have guttate, pustular or other non-plaque form of psoriasis; - Subjects only presenting with lesions on the scalp, face or intertriginous areas, not suitable for treatment with a topical adhesive plaster; - Subjects only presenting lesions 75 cm2; - Subjects presenting target lesions with one of the clinical signs or symptoms having a score of 0 (i.e. TSS total score <4); - Subjects having used topical antipsoriatic drugs during the 2 weeks before inclusion in this study; - Or having received topical retinoids for psoriasis within 4 weeks before inclusion; - Or having received any systemic antipsoriatic therapy (including intralesional corticosteroid, UVB programs or UVA/psoralen programs) within 4 weeks before inclusion; - Or having received any biological therapies targeting the immune responses involved in the pathogenesis of psoriasis within 1 year before inclusion; - Or having used any bland emollient on areas to be treated during the 48 hours preceding inclusion; - Subjects with ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients; - With history of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers may affect the outcome of the study; - Subjects with other dermatological conditions that could interfere with the assessment of the psoriatic lesions, according to the investigator’s opinion; - Any underlying disease or medication that severely compromise the patient's immune system; - Subjects in treatment with lithium or plaquenil. Subjects on a chronic, stable regimen of beta-blocker therapy may be included, but the dosage should not be modified for the whole duration of the study; - Subjects suffering from severe systemic diseases (e.g. cancer, severe acute infection); - Subjects with severe cardiac, renal or hepatic impairment; - Subjects suffering from psychiatric diseases, not allowing the observance of the protocol; history of current alcohol or drug abuse dated < 1 year; - Participation in the evaluation of any experimental drug or in any other type of clinical investigation concurrently or during 3 months before entering this study; - Subjects previously enrolled in this study; - Subjects not able to understand the purposes of the study; - Subjects refusing to give a written informed consent or unable to give a valid informed consent; - Subjects deprived of their freedom by administrative or legal decision, or being the subject of a legal protection measure, or out of state to express their consent; - Subjects not reliable, according to the investigator’s opinion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary endpoint of the study is to ascertain if Betesil® medicated plaster is as effective as the reference drug, when applied daily during a period of maximum 4 weeks on psoriasis plaques localised at elbows and knees.;Secondary Objective: Secondary endpoints are: the evaluation of the products safety and the record of patient’s acceptability of the treatments.;Primary end point(s): Total Severity Score (TSS) at 4-items, as evaluated by the Blind Assessor (the Principal Investigator or a designee) at the end of the treatment period (w4) will be considered as primary efficacy variable for this study. The results achieved in the two treatment groups will be compared statistically in order to assess the non-inferiority of the tested versus the reference treatment. Data will be analysed as ITT | — |
Countries
France, Italy
Outcome results
None listed