EUCTR2004-004825-87-HU进行中（未招募）不适用
Efficacy and safety of 0,1%, 0,5% and 1% TAZAROTENE nail lacquer formulation versus vehicle in nail psoriasis.International, multicenter, double-blind, randomized study of four parallel groups. - Dose ranging for Tazarotene nail lacquer
Pierre Fabre Dermatologie represented by Institut de Recherche Pierre Fabre0 个研究点目标入组 184 人开始时间: 2005年2月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 184
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •·Patient aged 18 years or over,
- •·Patient with a personal history of a cutaneous psoriasis,
- •·Patient with at least four nails with a minimal severity level defined as an onycholysis at least 25% or subungual hyperkeratosis at least 2 mm,
- •·Patient with a negative urine pregnancy test at inclusion for women of childbearing potential and using an efficient contraceptive (oral contraceptive, IUD, or tubal surgery)
- •·Patient accepting to participate in the study and to give written informed consent,
- •·For french patient : patient registered with the French Social Security, in agreement with the French law on biomedical experimentation.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •·Patient with a clinical diagnosis of onychomycosis or suspicion of an onychomycosis,
- •·Patient who has had a topical treatment for nail psoriasis within one month prior to the study (corticoids, retinoids, PUVAtherapy, vitamin D derivatives),
- •·Patient who has had a systemic treatment for psoriasis (biologics, methotrexate, cyclosporin, retinoids) within one month prior to the inclusion visit,
- •·Patient who has had an injection of corticosteroids in the nail within two months prior to the inclusion visit,
- •·Patient who has started or modified a treatment with beta-blockers within two months prior to the inclusion visit,
- •·Female who is pregnant, or breastfeeding, or not using contraception, or planning to become pregnant,
- •·Patient with a history of hypersensitivity to at least one ingredient of the test product,
- •·Patient who has a history of major medical/psychiatric illness or surgery which, in the judgment of the investigator, may interfere with study medication metabolism and/or study implementation and/or study parameter assessment,
- •·Patient with clinically significant laboratory abnormalities in investigator’s judgement of transaminases or cholesterol (total and HDL) or triglycerides,
- •·Patient who is not able to understand the information (for linguistic or psychiatric reasons) and to give informed consent,·Patient unwilling to give written informed consent,·Patient who has forfeited his/her freedom by administrative or legal decision or who is under guardianship,
- •·Participation in another clinical trial in the month preceding inclusion.
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