EUCTR2010-022284-35-FR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)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Orfagen
- 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.
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