JPRN-UMIN000029537已完成未知
Efficacy and safety of Targretin capsule 75-mg alone or in combination with phototherapy in Japanese patients with Cutaneous T-cell Lymphomas - Efficacy and safety of bexarotene or bexarotene plus phototherapy in CTC
agoya City University Graduate School of Medical Sciences Department of Geriatric and Environmental Dermatology0 个研究点目标入组 53 人开始时间: 2017年10月16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
- 53
研究概览
简要总结
We conducted the comparative study on the efficacy and safety between the Targretin monotherapy and the Targretin/phototherapy combination therapy for CTCL. In the efficacy, no difference was observed in the therapeutic effect of the two therapies evaluated by mSWAT and PGA at 8 weeks, but the two therapies have been shown to have therapeutic effects. In the combination therapy, 4 subjects were diagnosed to be the complete response, and it was suggested that the combination therapy may have a high effect.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1. Contraindications (severe liver failure, known hypersensitivity to bexarotene, systemic therapy with vitamin A or oral retinoid therapy at the entry in this study, hypervitaminosis A) 2. Patients with pregnancy, breast-feeding or intent to become pregnant 3. Skin-directed therapies, local chemotherapy, topical steroids, etc. within 2 weeks of study entry. Low- and mid-potency topical corticosteroids were allowed only for subjects using a stable dose regimen at least 2 weeks prior to study entry. High potency topical corticosteroids were not allowed permitted. 4. Prior therapy for the treatment of CTCL: therapy with UVA or UBV within 3 weeks of study entry 5. Prior therapy for the treatment of CTCL: radiotherapy within 4 weeks of study entry 6. Prior therapy for the treatment of CTCL: therapy with bexarotene within4 weeks of study entry 7. Known allergic reaction or hypersensitivity to bexarotene or other component of Targretin capsules 8. History of severe allergic reaction or hypersensitivity to any other drugs or prior therapy for the treatment of CTCL 9. Unwillingness or inability to minimize exposure to sunlight and antificial UV light while receiving bexarotene 10. Principal investigator or subinvestigator judged inadequate
研究者
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