ISRCTN86666250已完成不适用
Efficacy and tolerance of tazarotene cream in lamellar ichthyosis (LI): a dose-finding study
Orfagen (France)0 个研究点目标入组 30 人开始时间: 2008年2月14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
- 30
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. Patients of both sexes of at least 8 years of age
- •2. Patients with a documented diagnosis of LI based on clinical signs and, if possible, pedigree analysis
- •3. Patients with both scaling and roughness of moderate to severe intensity on each side of the body
- •4. Patients or patient's parents/guardians able to understand and follow the study procedures
- •5. Written informed consent from the patients or parents/guardians
- •6. Patients or patients' parents/guardians affiliated to a healthcare security system
排除标准
- •1. Patients under 8 years of age
- •2. Pregnant women, lactating mothers or women of childbearing potential with no reliable medical contraception (combined oral contraceptive, intra-uterine contraceptive device) and unwilling to use condoms, up to 8 weeks after the last test product application
- •3. Women of childbearing potential with a positive systemic pregnancy test at baseline
- •4. Patients with congenital ichthyoses other than LI
- •5. Patients with an erythrodermic component of LI (EARLI)
- •6. Patients with LI of mild severity on at least one side of the body
- •7. Patients with lesional superinfection
- •8. Patients with skin or systemic disease likely to interfere with the study or the evaluation parameters
- •9. Patients with a known contact allergy to one of the ingredients contained in the test products
- •10. Patients with sunburn, or excessive pruritus, burning, skin redness or peeling, not fully recovered
- •11. Patients treated with topicals (e.g., vitamin A analogues, vitamin D analogues) within 14 days prior to baseline
- •12. Patients treated with keratolytics (e.g., urea, hydroxy-acids) or moisturizers other than the standard moisturizer within 7 days prior to baseline
- •13. Patients treated with concomitant dermatological medications and cosmetics that have a strong drying effect within 7 days prior to baseline
- •14. 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
- •15. Patients treated with drugs known to be photosensitizers (e.g., thiazides, tetracyclines, quinolones, phenothiazines, sulfonamides, hydrochlorates, chlorpromazine, psoralen, amiodarone, tar) within 2 weeks prior to baseline
- •16. Patients treated with UV therapy or patients medically exposed to UV within 4 weeks prior to baseline
- •17. Patients having significant sun exposure due to their occupation
- •18. Patients with inherent sensitivity to sunlight
- •19. Patients who participated in a study within the 3 months prior to study entry
- •20. Patients living with a family member who is currently under test treatment, i.e. Period I of the study (from baseline to day 28)
- •21. Patients or patients' parents/guardians who are unable to understand and/or to follow the study procedures and patient instructions
- •22. Patients or patients' parents/guardians who are unwilling to give written informed consent
研究者
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