ISRCTN62739763已完成2 期
Phase IIB dose response and safety study of topical formulations of methotrexate (MQX-5902, MQX-5904 and MQX-5906) in the treatment of fingernail psoriasis
MediQuest Therapeutics, Inc. (USA)0 个研究点目标入组 83 人开始时间: 2008年4月24日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 83
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. Diagnosed moderate fingernail psoriasis of at least two fingernails
- •2. Stable and unchanged psoriasis therapies for two months and must not have received methotrexate for three months prior to screening
- •3. Female patients who are not five years post menopausal or surgically sterile must use appropriate birth control for specified time periods and have negative pregnancy tests
- •4. 18 - 75 years of age and either sex
排除标准
- •1. Target or control fingernails that are thicker than 2 mm, abnormal or infected (bacterial or fungal)
- •2. Patients with immunosuppression, human immunodeficiency virus (HIV), or neuropathies of the hand
- •3. Use of any methotrexate preparation, any topical anti-psoriatic medications or ultraviolet treatment within two months of study visit one
- •4. Use of more that one two-week course of oral corticosteroid therapy or one injection during three months prior to the screening visit
- •5. Use of manicures or cosmetic nail products during and within seven days of the start of treatment
- •6. Use of any drug known to have potential for toxicity to a major organ during and within 90 days prior to the start of treatment
- •7. Patients who are nursing, pregnant or plan to become pregnant or father a child within the study time frame including within three months of the last dose of study medication
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