ACTRN12607000447459终止1 期
A Phase 1/2 Single Center, Randomized, Double-blind, Placebo-controlled, Left-Right Comparison Study to Evaluate the Safety and Preliminary Efficacy of a Topical Antimicrobial (NEO101) in Older Adolescents and Adults with at least Moderate Atopic Dermatitis
eosil Inc.0 个研究点目标入组 15 人开始时间: 2007年8月31日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 16 Years 至 50 Years（—）
- 性别
- All
入选标准
- •Diagnosed with atopic dermatitis as defined by pruritus, eczmetatous dermatitis, personal or family history of atopy; have a Physician's Global Assessment score equivalent to mild-to-moderate atopic dermatitis at Screening and Day 1; have a target treatment area of 50-150 cm squared on both a left and a right side of the body; have a positive culture for Staphylococcus aureus on both target treatment areas; compliant with defined birth control.
排除标准
- •Have concomitant dermatologic or medical condition(s) which may interfere with the investigator's ability to evaluate subject response; have immunocompromised status; have any clinically significant abnormal clinical laboratory test results at screening; have a history of malignancy not in remission for at least 5 years excluding basal cell carcinoma and nonperiorificial squamous cell carcinoma of the skin; have an active intercurrent infection; have used any topical antibiotic or antibacterial soap or bleach baths within 72 hours prior to Day 1; have used any systemic antibiotic within 1 week prior to Day 1; have a history of hypersensitivity or allergic reactions to parabens, sodium sulfite or other ingredient in the vehicle formulation.
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