ISRCTN34974208已完成不适用
Multicentre, prospective, assessor-blind, in parallel groups randomised and controlled trial of the efficacy and safety of betamethasone valerate 2.25mg medicated plaster (Betesil®) versus 50µg-0,5mg/g calcipotriol-betamethasone (dipropionate) ointment (Daivobet®/Dovobet®), in the treatment of chronic plaque psoriasis
Institut Biochimique SA (IBSA) (Switzerland)0 个研究点目标入组 300 人开始时间: 2010年6月17日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Out-patients of either sex
- •2. Aged 18 years or more
- •3. With diagnosis of mild-to-moderate (Total Severity Score [TSS] = 4, as judged by the Investigator), stable, chronic plaque psoriasis, for at least 12 months
- •4. 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)
- •5. Not requiring systemic treatment
- •6. 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)
- •7. 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
- •8. Subjects must sign a written informed consent to the participation prior to inclusion in the study
- •9. For France only: Subjects covered by an insurance policy
排除标准
- •1. 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 Guideline
- •2. Pregnant or lactating women
- •3. Subjects who have guttate, pustular or other non-plaque form of psoriasis
- •4. Subjects only presenting with lesions on the scalp, face or intertriginous areas, not suitable for treatment with a topical adhesive plaster
- •5. Subjects only presenting lesions <10 cm2 or >75 cm2
- •6. Subjects with more severe stage of chronic plaque psoriasis presenting target lesions with one of the clinical signs or symptoms having a score of 0 (i.e. TSS total score <4)
- •7. Subjects needing a systemic therapeutic approach in order to control the disease
- •8. Subjects having used topical anti-psoriatic drugs during the 2 weeks before inclusion in this study
- •9. Or having received topical retinoids for psoriasis within 4 weeks before inclusion
- •10. Or having received any systemic anti-psoriatic therapy (including intralesional corticosteroid, vitamin D in high doses, vitamin D analogues, methotrexate, cyclosporine, UVB programs or UVA/psoralen programs) within 4 weeks before inclusion
- •11. Or having received any biological therapies targeting the immune responses involved in the pathogenesis of psoriasis within 1 year before inclusion
- •12. Or having used any bland emollient on areas to be treated during the 48 hours preceding inclusion
- •13. Subjects with ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients
- •14. Subjects with history of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers may affect the outcome of the study
- •15. Subjects with other dermatological conditions that could interfere with the assessment of the psoriatic lesions, according to the investigator?s opinion
- •16. Subjects with any underlying disease or medication that severely compromise the subject's immune system;
- •17. Subjects in treatment with lithium or hydroxychloroquine (Plaquenil®)
- •18. Subjects on a chronic, stable regimen of ?-blocker therapy may be included, but the dosage should not be modified for the whole duration of the study
- •19. Subjects suffering from severe systemic diseases (e.g. cancer, severe acute infection)
- •20. Subjects with severe cardiac, renal or hepatic impairment
- •21. Subjects suffering from psychiatric diseases, not allowing the observance of the protocol; history of current alcohol or drug abuse dated < 1 year
- •22. Subjects enrolled in the evaluation of any experimental drug or in any other type of clinical investigation concurrently or during 3 months before entering this study
- •23. Subjects previously enrolled in this study
- •24. Subjects not amenable to topical treatment
- •25. Subjects not able to understand the purposes of the study
- •26. Subjects refusing to give a written informed consent or unable to give a valid informed consent
- •27. 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
- •28. Subjects not reliable, according to the investigator?s opinion
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