跳至主要内容
临床试验/EUCTR2016-002860-15-DE
EUCTR2016-002860-15-DE进行中(未招募)1 期

A Multi-Center, Randomized, Double-Blind, Parallel-Group Vehicle Controlled Study To Compare The Efficacy And Safety Of CD5789 50µg/g Cream Versus Vehicle Cream In Subjects With Acne Vulgaris - Double-Blind Efficacy and Safety of CD5789 50µg/g Cream versus Vehicle cream in acne vulgaris

Galderma R&D SNC0 个研究点目标入组 1,200 人开始时间: 2016年10月20日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
1,200

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • - Male or female, 9 years of age and older), at the Screening visit. For Russia: Male or female, 9-17 years of age OR 18 years and older, at the
  • Screening visit
  • - The Subject has a facial acne severity grade of 3 (moderate) on the Investigator Global Assessment (IGA) scale at Screening and Baseline.
  • - The subject has a minimum of 20 inflammatory lesions and 25 noninflammatory lesions on the face at Screening and Baseline.
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range: 1200
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 622
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 2

排除标准

  • - The subject has severe forms of acne (e.g., acne conglobata, acne fulminans) or secondary acne form (e.g.,chloracne, drug-induced acne, etc.).
  • - The subject has more than 1 nodule on the face at Screening and Baseline.
  • - The subject has more than 1 nodule on the trunk at Screening and Baseline.

研究者

发起方
Galderma R&D SNC

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