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临床试验/EUCTR2011-004791-11-GB
EUCTR2011-004791-11-GB进行中(未招募)1 期

Efficacy and safety of CD5024 1% cream versus metronidazole 0.75% cream in subjects with papulopustular rosacea over 16 weeks treatment, followed by a 36-week extension period

Galderma R&D SNC0 个研究点目标入组 962 人开始时间: 2012年1月17日最近更新:
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
962

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

入选标准

  • - Male or female subjects 18 years of age or older at the Screening Visit,
  • - Subjects with papulopustular rosacea scored 3 (moderate) or 4 (severe) according to the Investigator Global Assessment (IGA) at Screening and Baseline visits,
  • - Subjects with at least 15 but not more than 70 inflammatory lesions (papules and pustules) on the face at Screening and Baseline visits.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 380
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 580

排除标准

  • - Subjects with particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated pustulosis of the chin) or other facial dermatoses that may be confounded with papulopustular rosacea, such as peri oral dermatitis, facial keratosis pilaris, or seborrheic dermatitis and acne at Screening and Baseline visits,
  • - Subjects with rosacea with more than two nodules on the face at Screening and Baseline visits.

研究者

发起方
Galderma R&D SNC

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