Efficacy and safety of CD5024 1% in acne vulgaris

Galderma R&D SNC0 个研究点目标入组 60 人开始时间: 2016年3月4日最近更新: 2017年8月21日

适应症

试验速览

暂无简介。

•1. The subject is a male or a female aged from 18 to 35 years old before screening visit.
•2. The subject has a medical diagnosis of acne vulgaris defined by :
•2.1. at least 20 (twenty) inflammatory lesions and a maximum of 100 (one hundred) non-inflammatory lesions (nose is excluded for the lesion count) (Screening and Baseline)
•2.2. symmetry of the lesions: No more than twice as many acne lesions on one side as compared to the other side
•3. If the subject is a female of childbearing potential, she must agree to use an effective contraceptive method for the duration of the study
•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 60
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. The subject has an underlying known disease surgical or medical condition, in the opinion of the investigator might interfere with interpretation of the study results or put the subject at risk (e.g., other dermatological diseases affecting the treatment area, such as a dermatitis, eczema, etc., or any uncontrolled chronic or serious diseases which would normally prevent participation in any clinical study, such as a cancer, leukemia or severe hepatic impairment), (Screening).
•2. The subject has acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), nodulo cystic acne, or acne requiring systemic treatment.
•3. The subject has a known or suspected allergies or sensitivities to any components of any of the study drugs (see Investigator’s Brochure/Product label).
•4. The subject is a male with beard or facial hair, which would interfere with clinical evaluation or clinical procedure (Screening and Baseline).

发起方

Galderma R&D SNC