NCT03034460已完成2 期
Efficacy and Safety of CD5024 1% in Acne Vulgaris
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 70
- 试验地点
- 3
- 主要终点
- Inflammatory Lesion Count (Papules and Pustules) at Day 40
研究概览
简要总结
Exploratory, multi-center, randomised, investigator-blinded, vehicle controlled study using intra-individual comparison involving subjects with acne vulgaris on face to evaluate the efficacy of CD5024 1% cream over a 6-week treatment period compared to its vehicle.
详细描述
Study drugs application will be performed once daily, 5 days a week during 6 weeks
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject is a male or a female aged from 18 to 35 years old at screening visit.
- •The subject has a medical diagnosis of acne vulgaris :
- •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) at Baseline
- •2.2 symmetry of the lesions: No more than twice as many acne lesions on one side as compared to the other side at Baseline
- •If the subject is a female of childbearing potential, she must agree to use an effective contraceptive method for the duration of the study
排除标准
- •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).
- •The subject has acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), nodulo cystic acne, or acne requiring systemic treatment.
- •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).
- •The subject is a male with beard or facial hair, which would interfere with clinical evaluation or clinical procedure (Screening and Baseline).
研究组 & 干预措施
CD5024 1% cream
Experimental
Active drug;
干预措施: CD5024 1% cream (Drug)
CD5024 cream placebo
Placebo Comparator
Placebo of active drug;
干预措施: CD5024 cream placebo (Drug)
CD0271/CD1579 gel
Other
Positive control;
干预措施: CD0271/CD1579 gel (Drug)
CD0271/CD1579 gel placebo
Other
Placebo of positive control;
干预措施: CD0271/CD1579 gel placebo (Drug)
结局指标
主要结局
Inflammatory Lesion Count (Papules and Pustules) at Day 40
时间窗: Day 40
Inflammatory lesion count corresponded to the sum of papules and pustules.
次要结局
- Percent Reduction From Baseline (Day 1) in Total Lesions at Day 40(Baseline (Day 1), and Day 40)
- Percent Reduction From Baseline in Non-Inflammatory Lesion at Day 40(Baseline (Day 1), and Day 40)
- Number of Participants With Adverse Events (AEs)(From start of study up to follow up (Week 7))
- Number of Participants Reported Worst Local Tolerability Score on Treated Areas (Face and Ear) From Day 1 to Follow up (Week 7)(From Day 1 up Follow up (Week 7))
- Inflammatory Lesion Count (Papules and Pustules) at Baseline (Day 1)(Baseline (Day 1))
- Number of Participants Reported for Investigator's Preference on a 5-Point Scale at Day 40(Day 40)
- Percent Reduction From Baseline (Day 1) in Inflammatory Lesion Count at Day 40(Baseline (Day 1), and Day 40)
- Total Lesion Count at Baseline (Day 1) and Day 40(Baseline (Day 1), and Day 40)
- Non-Inflammatory Lesion Count at Baseline (Day 1) and Day 40(Baseline (Day 1), and Day 40)
- Number of Participants Reported for Participant's Preference on 5-Point Scale at Day 40(Day 40)
研究者
研究点 (3)
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