EUCTR2006-006878-22-FR进行中（未招募）1 期
Efficacy and tolerance of Tazarotene cream in lamellar ichthyosis (LI): a dose-finding study.
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
- 32
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
- •- Patients of both sexes of at least 8 years of age,
- •- Patients with a documented diagnosis of LI based on clinical signs and, if possible, pedigree analysis,
- •- Patients with both scaling and roughness of moderate to severe intensity (scaling and roughness with a score of at least 2) on each side of the body,
- •- Patients or patient’s parents/guardians able to understand and follow the study procedures,
- •- Written informed consent from the patients or parents/guardians,
- •- Patients or patients’ parents/guardians affiliated to a healthcare security system.
- •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 8 years of age,
- •- Pregnant women, lactating mothers or women of childbearing potential with no reliable medical contraception (neither oral contraception, nor intra-uterine contraceptive device),
- •- Women of childbearing potential unwilling to have a reliable contraception from the study enrollment to at least 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 mild severity (score < 2 for scaling or roughness) on at least one side of the body,
- •- Patients with lesional superinfection,
- •- Patients with skin or systemic disease likely to interfere with the study or the evaluation parameters,
- •- 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 keratolytics (e.g. urea, hydroxy-acids) or moisturizers other than the standard moisturizer 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 who participated in a study within the 3 months prior to study entry,
- •- Patients living with a family member who is currently under test treatment, i.e. Period I of the study (from baseline to day 28),
- •- 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 written informed consent.
研究者
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