A Randomized, Multi-center, Investigator-blind, Vehicle- and Active-controlled, Phase 2 Study to Assess the Efficacy and Safety of Different Concentrations of CD5789 Cream Applied Once Daily in Subjects With Moderate to Severe Acne Vulgaris
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 304
- 试验地点
- 24
- 主要终点
- Percentage of Participants With Success Rate 1 (SR1)
研究概览
简要总结
To assess the efficacy and safety of different concentrations of CD5789 cream in participants with acne vulgaris for the purpose of dose identification.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female participant, 12 to 35 years old with the following characteristics:
- •Facial acne severity grade of the following:
- •Stratum 1: IGA score of 3 or 4
- •Stratum 2: IGA score of 4
- •Stratum 3: IGA score of 3 or 4
- •A minimum of 30 non-inflammatory lesions and fulfills the criteria of one of the following strata:
- •Stratum 1: A minimum of 20 but not more than 40 inflammatory lesions, and a maximum of one nodule on the face.
- •Stratum 2: More than 40 inflammatory lesions, and up to four nodules on the face.
- •Stratum 3: Participants of Japanese origin with at least 20 inflammatory lesions and up to four nodules on the face.
- •Note: Participants of Japanese origin will not be included in Stratum 1 or Stratum
- •Japanese origin is defined as all four grandparents were born in Japan.
排除标准
- •The presence of severe forms of acne (acne conglobata, acne fulminans) or secondary acne form (chloracne, drug-induced acne, etc.)
- •Any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with the interpretation of the clinical trial results and/or put the participant at significant risk (according to the Investigator's judgment) if the participant participates in the clinical trial.
- •Known or suspected allergies or sensitivities to any components of any of the study drugs.
- •Current participation in any other clinical trial of a drug or device OR past participation within the 30 days prior to the Baseline visit.
研究组 & 干预措施
CD5789 25 mcg/g Cream
Participants randomized in stratum 1, 2 and 3 were applied with 25 mcg/g CD5789 cream, once daily for 12 weeks.
干预措施: CD5789 25 µg/g cream (Drug)
CD5789 50 mcg/g Cream
Participants randomized in stratum 1, 2 and 3 were applied with 50 mcg/g CD5789 50 once daily for 12 weeks.
干预措施: CD5789 50 µg/g cream (Drug)
CD5789 100 mcg/g Cream
Participants randomized in stratum 1, 2 and 3 were applied with 100 mcg/g CD5789 cream, once daily for 12 weeks.
干预措施: CD5789 100 µg/g cream (Drug)
Tazarotene 0.1% Gel
Participants randomized in stratum 1 and 2 were applied with Tazarotene 0.1% Gel, once daily for 12 weeks.
干预措施: Tazarotene 0.1% gel (Drug)
Vehicle Cream
Participants randomized in stratum 1, 2 and 3 were applied with Vehicle Cream once daily for 12 weeks.
干预措施: Vehicle cream (Drug)
结局指标
主要结局
Percentage of Participants With Success Rate 1 (SR1)
时间窗: From Baseline at Week 12
Success Rate 1 was defined as percentage of participants who achieved at least a two-point reduction in the Investigator Global Assessment (IGA) scale from baseline at week 12. Evaluation of acne was performed by the investigator based on the following 5 point scale: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, higher score indicated higher severity. All missing values were imputed by last observation carried forward (LOCF).
Percentage Change From Baseline in Total Lesion Counts at Week 12 Using Last Observation Carried Forward (LOCF)
时间窗: Baseline, Week 12
The lesion counts were performed by the Investigator. Total lesion counts was the sum of inflammatory, non-inflammatory lesions and nodules. All missing values were imputed by LOCF.
Absolute Change From Baseline in Total Lesion Lesion Counts at Week 12 Using Last Observation Carried Forward (LOCF)
时间窗: Baseline, Week 12
The lesion counts were performed by the Investigator. Total lesion counts was the sum of inflammatory, non-inflammatory lesions and nodules. All missing values were imputed by LOCF.
次要结局
- Percentage of Participants With Success Rate 2 (SR2)(From Baseline to Week 12)
- Percentage Change From Baseline in Inflammatory and Non-inflammatory Lesion Count up to Week 12 Using Last Observation Carried Forward (LOCF)(Baseline, Week 12)
- Absolute Change From Baseline in Inflammatory and Non-inflammatory Lesion Count up to Week 12 Using Last Observation Carried Forward (LOCF)(Baseline, Week 12)