Multicentre, prospective, assessor-blind, in parallel groups randomised and versus reference marketed product controlled confirmatory trial of the efficacy and safety of Institut Biochimique SA (IBSA) 0.1% betamethasone valerate (BMV) medicated plaster for the treatment of chronic plaque psoriasis

Institut Biochimique SA (IBSA) (Switzerland)0 sites180 target enrollmentFebruary 11, 2010

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Not specified
Sponsor: Institut Biochimique SA (IBSA) (Switzerland)
Enrollment: 180
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

February 11, 2010

End Date

June 11, 2008

Last Updated

3 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Institut Biochimique SA (IBSA) (Switzerland)

Eligibility Criteria

Inclusion Criteria

•1\. Subjects (outpatients) of both genders
•2\. Aged 18 years or more
•3\. Suffering from stable chronic plaque psoriasis (psoriasis vulgaris), involving less than 10% of the body surface area (BSA) (i.e. mild to moderate psoriasis according to CHMP/EWP/2454/02corr19\) and presenting with psoriatic plaques in extensory skin areas, i.e. elbow and/or knee
•4\. Have at least two plaques on extensory parts of limbs that must be each greater than or equal to 10 cm^2 but less than 150 cm^2 (surface area equivalent of two BMV medicated plasters). These plaques, defined as target areas, will be treated with the tested formulation, BMV medicated plaster, or with the comparator product, BMV 0\.1% cream (not occluded), according to a computer generated, fully randomised sequence. When present, other affected skin areas, different from those identified as target plaques, will be treated only with a bland emollient (5% urea) during the whole treatment period.
•5\. Female subjects of childbearing potential (i.e., not status post hysterectomy or tubal ligation) must use an appropriate method of contraception according to the definition of Note 3 of ICH M3 Guideline; pregnant or breast\-feeding women will not be included
•6\. Ability to comprehend the full nature and purpose of the study, including possible risks and side effects
•7\. Ability to cooperate with the Investigator and to comply with the requirements of the entire study
•8\. Signed written informed consent prior to inclusion in the study

Exclusion Criteria

•1\. Guttate, pustular or other non\-plaque form of psoriasis
•2\. More severe stage of chronic plaque psoriasis, needing a systemic therapeutic approach in order to control the disease and not amenable to topical treatment
•3\. No concurrent dermatological conditions that could interfere with the assessment of the psoriatic lesion
•4\. No underlying disease or medication that severely compromise the patient's immune system
•5\. No history of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers to potentially affect the outcome of the study
•6\. No use of topical anti\-psoriatic drugs during the two weeks before inclusion in this study
•7\. No use of a topical retinoids during the 4 weeks before inclusion in this study
•8\. No systemic antipsoriatic therapy (e.g. corticosteroids \- including intralesional corticosteroid, vitamin D in high doses, vitamin D analogs, methotrexate, cyclosporin, UVB programs or UVA/psoralen programs) within 4 weeks before inclusion
•9\. No participation in the evaluation of any investigational drug during 3 months before the study