Multicentre, prospective, assessor-blind, in parallel groups randomised and controlled trial of the efficacy and safety of betamethasone valerate 2.25mg medicated plaster (Betesil®, IBSA-Institut Biochimique S.A.) versus 50µg-0,5mg/g calcipotriol-betamethasone (dipropionate) ointment (Daivobet®/Dovobet®, LEO Pharmaceutical Products), in the treatment of chronic plaque psoriasis.

IBSA, Institut Biochimique SA0 sites0 target enrollmentDecember 17, 2009

Overview

No summary available.

Registry

who.int

Start Date

December 17, 2009

End Date

January 27, 2011

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

IBSA, Institut Biochimique SA

•\- 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 \<75 cm2 (surface area equivalent of one BMV medicated plasters);
•\- Female subjects of childbearing potential (i.e., not status post hysterectomy or tubal ligation) must be using an appropriate method of contraception and must be willing to continue using it throughout the whole study period ;
•\- Female subjects of childbearing potential must have a negative urine pregnancy test at the screening visit;
•\- Subjects must be able to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co\-operate with the Investigator, to comply with the requirements of the entire study and to return for the required examinations;
•\- Subjects must sign a written informed consent to the participation prior to inclusion in the study

•\- 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 \<10 cm2 or \>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;