EUCTR2010-022284-35-IT进行中（未招募）不适用
CLINICAL EFFICACY AND SAFETY OF TAZAROTENE CREAM 0.05% IN THE INITIAL AND MAINTENANCE THERAPIES OF LAMELLAR ICHTHYOSIS (LI) - ND
ORFAGE0 个研究点目标入组 80 人开始时间: 2011年2月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
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
- •Male or female patients of at least 9 years old, Patients with a documented diagnosis of LI based on clinical signs, histopathology and/or genotype and, when possible, pedigree analysis, Patients requiring topical treatment by keratolytics either as monotherapy or as alternate therapy to oral retinoids, Patients with a global score of at least 3 for each parameter scaling and roughness, according to the scale used for primary efficacy parameter, Patients or patient’s parents/guardians able to understand and follow the study procedures, Written informed consent from the patients or parents/guardians, Written informed consent (personally signed and dated) from the patients and/or parent(s)/guardian(s) (according to local legislation). Patients or patients’ parents/guardians affiliated to a healthcare security system (when applicable in the national regulation).
- •Are the trial subjects under 18? yes
- •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
- •Patients under 9 years of age, Pregnant or lactating women, Women of childbearing potential with no reliable medical contraception (oral contraceptive, intra-uterine contraceptive device), and unwilling to use condoms up to 8 weeks after the last test product application, Women of childbearing potential with a positive systemic pregnancy test at baseline, Patients with congenital ichthyoses other than LI, Patients with an erythrodermic component of LI (EARLI), Patients with LI of overall severity < 3 for scaling or roughness, according to the scale used for primary efficacy parameter, Patients with lesional superinfection, Patients with skin or other disease likely to interfere with the study conduct or the evaluation parameters, Patients with excessive pruritus, burning, skin redness or peeling, not fully recovered at baseline, Patients with inherent sensitivity to sunlight, Patients with a known contact allergy to one of the ingredients contained in the test products, Patients treated with topicals (e.g. vitamin A analogues, vitamin D analogues) within 14 days prior to baseline, Patients treated with tazarotene gel within 28 days prior to baseline, Patients treated with keratolytics (e.g. urea, hydroxy-acids) or moisturizers other than the standard moisturizer within 7 days prior to baseline, Patients treated with concomitant dermatologic medications and cosmetics that have a strong drying effect within 7 days prior to baseline, Patients treated with oral retinoids during the preceding 28 days, or with oral vitamin A supplementation (more than 3000 IU per day) during the preceding 7 days of baseline, Patients treated with drugs known to be photosensitizers (e.g. thiazides, tetracyclines, quinolones, phenothiazines, sulfonamides, hydrochlorates, chlorpromazine, psoralen, amiodarone, tar) within 14 days prior to baseline, Patients with a medical condition that potentially alters bone metabolism (e.g. osteoporosis, thyroid dysfuntion, Cushing syndrome) or treated with a medication interfering with bone activity (e.g. corticosteroids, thyroid hormones, vitamin D analogues, cytotoxics, biphospbonates, calcitonins, tetracyclines, quinolones, thiazides, salicylates in long-term course, heparin, theophylline, barbiturates, colchicines) within the preceding 56 days prior to baseline, Patients treated with UV therapy or patients medically exposed to UV within 28 days prior to baseline, Patients having significant sun exposure due to their occupation, Patients who participated in a study within the 3 months prior to study entry, Patients or patients’ parents/guardians who are unable to understand and/or to follow the study procedures and patient instructions, Patients or patients’ parents/guardians who are unwilling to give personally signed and dated written informed consent.
研究者
相似试验
进行中（未招募）
不适用
Efficacy and tolerance of Tazarotene cream in lamellar ichthyosis (LI): a dose-finding study.amellar Ichthyosis (LI)EUCTR2006-006878-22-DEOrfagen
进行中（未招募）
1 期
Efficacy and tolerance of Tazarotene cream in lamellar ichthyosis (LI): a dose-finding study.EUCTR2006-006878-22-FROrfagen32
已完成
不适用
Efficacy and tolerance of tazarotene cream in lamellar ichthyosis (LI): a dose-finding studyon Erythrodermic Autosomic Recessive Lamellar Ichthyosis (NEARLI)Congenital ichthyosisISRCTN86666250Orfagen (France)30
进行中（未招募）
不适用
CLINICAL EFFICACY AND SAFETY OFTAZAROTENE CREAM 0.05% IN THE INITIALAND MAINTENANCE THERAPIES OF LAMELLAR ICHTHYOSIS (LI)amellar Ichtyosis (LI)EUCTR2010-022284-35-ATOrfagen80
进行中（未招募）
1 期
CLINICAL EFFICACY AND SAFETY OFTAZAROTENE CREAM 0.05% IN THE INITIALAND MAINTENANCE THERAPIES OF LAMELLAR ICHTHYOSIS (LI)amellar Ichtyosis (LI)EUCTR2010-022284-35-FROrfagen80