ISRCTN62315004已完成未知
Clinical efficacy and safety of R0002 cream in the initial and maintenance therapies of lamellar ichthyosis (LI): a randomised controlled trial
Orfagen (France)0 个研究点目标入组 80 人开始时间: 2011年6月17日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 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
入排标准
- 性别
- All
入选标准
- •1. Male or female patients of at least 9 years old
- •2. Patients with a documented diagnosis of LI based on clinical signs, histopathology and/or genotype and, when possible, pedigree analysis
- •3. Patients requiring topical treatment by keratolytics either as monotherapy or as alternate therapy to oral retinoids
- •4. Patients with a global score of at least 3 for each parameter scaling and roughness, according to the scale used for primary efficacy parameter
- •5. Patients or patient?s parents/guardians able to understand and follow the study procedures
- •6. Written informed consent (personally signed and dated) from the patients and/or parent(s)/ guardian(s) (according to local legislation)
- •7. Patients or patients? parents/guardians affiliated to a healthcare security system (when applicable in the national regulation)
排除标准
- •1. Patients under 9 years of age
- •2. Pregnant or lactating women
- •3. 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
- •3.1. [For german centers only] Young girls (9-17 years old) who are already of child bearing potential but not already taking a medical contraception (oral contraceptive, intra uterine contraceptive device) beforehand to the clinical trial, and unwilling to use condoms up to 8 weeks after the last test product application
- •4. Women of childbearing potential with a positive systemic pregnancy test at baseline
- •5. Patients with congenital ichthyoses other than LI
- •6. Patients with an erythrodermic component of LI (EARLI)
- •7. Patients with LI of overall severity < 3 for scaling or roughness, according to the scale used for primary efficacy parameter
- •8. Patients with lesional superinfection
- •9. Patients with skin or other disease likely to interfere with the study conduct or the evaluation parameters
- •10. Patients with excessive pruritus, burning, skin redness or peeling, not fully recovered at baseline
- •11. Patients with inherent sensitivity to sunlight
- •12. Patients with a known contact allergy to one of the ingredients contained in the test products
- •13. Patients treated with topicals (e.g. vitamin A analogues, vitamin D analogues) within 14 days prior to baseline
- •14. Patients treated with tazarotene gel within 28 days prior to baseline
- •15. Patients treated with keratolytics (e.g. urea, hydroxy-acids) or moisturisers other than the standard moisturiser within 7 days prior to baseline
- •16. Patients treated with concomitant dermatologic medications and cosmetics that have a strong drying effect within 7 days prior to baseline
- •17. 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
- •18. Patients treated with drugs known to be photosensitisers (e.g. thiazides, tetracyclines, quinolones, phenothiazines, sulfonamides, hydrochlorates, chlorpromazine, psoralen, amiodarone, tar) within 14 days prior to baseline
- •19. 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
- •20. Patients treated with ultraviolet (UV) therapy or patients medically exposed to UV within 28 days prior to baseline
- •21. Patients having significant sun exposure due to their occupation
- •22. Patients who participated in a study within the 3 months prior to study entry
- •23. Patients or patients? parents/guardians who are unable to understand and/or to follow the study procedures and patient instructions
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