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临床试验/ACTRN12606000424505
ACTRN12606000424505已完成1 期

A Phase 1 Single-Center, Randomized, Placebo-Controlled, Double-Blind Pilot Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of a Candidate Topical Antimicrobial (NEO101) in the Reduction of Propionibacterium acnes among Healthy Young Adult Men

eosil, Inc.0 个研究点目标入组 30 人开始时间: 2006年10月3日最近更新:
适应症

试验速览

阶段
1 期
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
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
18 Years 至 45 Years(—)
性别
Male

入选标准

  • Sign an informed consent;- are in general good health;-do not have active acne lesions on the forehead;- are colonized with P. acnes, as demonstrated by a screening culture with a P. acnes count of >10,000/cm2 on facial skin (forehead);- have not used any form of topical or systemic antibiotics within 28 days prior to enrollment;- compliant with adequate birth control (defined).

排除标准

  • Have concomitant dermatologic or medical condition(s) which may interfere wtih the investigator's ability to evaluate the subject's response to the study drug;- have atopic dermatitis, active allergic rhinitis, or nasal polyps, seborrheic dermatitis or psoriasis, or any facial piercing;- have a history of hypersensitivity or allergic to parabens, sodium sulfite or any other ingredient in the vehicle formulation.

研究者

发起方
eosil, Inc.

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