A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study to Determine the Therapeutic Equivalence of GDC 268 and Clindamycin Phosphate Topical Lotion, 1% in Subjects With Acne Vulgaris
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,236
- 试验地点
- 34
- 主要终点
- Mean Percent Change in the Number of Inflamed Lesions
研究概览
简要总结
The objective of the study is to evaluate the safety, tolerability, and therapeutic equivalence of GDC 268 to Clindamycin Phosphate Topical Lotion, 1% and to compare the efficacy of these two products to the GDC vehicle lotion (i.e., placebo) in the treatment of acne vulgaris.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or non-pregnant, non-lactating female, ≥12 and ≤40 years of age with a clinical diagnosis of acne vulgaris.
- •Must have ≥ 25 but ≤ 100 non-inflammatory lesions (open and closed comedones) AND ≥ 20 but ≤ 70 inflammatory lesions (papules and pustules) AND ≤ 2 nodulocystic lesions (nodules and cysts) on the face (e.g., forehead, nose, cheeks, chin, upper lip) at Baseline.
- •Must be willing and able to refrain from use of all other topical products in the treatment area, all acne medications other than test article, and all antibiotics (other than test article) during the 12-week treatment period.
- •Women must be surgically sterile, or use an effective method of birth control with a negative urine pregnancy test (UPT) at the Baseline Visit (Day 1).
- •In good general health and free of any other clinically significant disease state or physical condition.
- •Subject has provided written informed consent / assent.
排除标准
- •Subject is pregnant, breastfeeding, or is planning to become pregnant or breastfeed during the study.
- •Subject has more than 2 facial nodular lesions; any nodules present will be documented but not included in the inflammatory lesion count for analysis.
- •Subject has excessive facial hair (e.g., beards, sideburns, moustaches), facial tattoos, or other facial attributes that would interfere with diagnosis or assessment of acne vulgaris in the opinion of the investigator.
- •Subject is planning surgery during the study.
- •Subject has a history of hypersensitivity or allergy to clindamycin or lincomycin and/or any of the ingredients in the test articles.
- •Other Eligibility Criteria not listed above will be reviewed for each prospective subject by the study staff.
研究组 & 干预措施
Test product
GDC 268 Lotion applied topically as directed.
干预措施: GDC 268 Lotion (Drug)
Reference Product
Clindamycin Phosphate Lotion, 1% applied topically as directed.
干预措施: Clindamycin Phosphate Lotion 1% (Drug)
Placebo
GDC Vehicle lotion applied topically as directed.
干预措施: GDC Vehicle Lotion (Drug)
结局指标
主要结局
Mean Percent Change in the Number of Inflamed Lesions
时间窗: 12 weeks
Percent Change from Baseline to Week 12 in inflammatory lesion counts (Papules/Pustules).
Mean Percent Change in the Non-inflammatory Lesion Counts
时间窗: 12 weeks
Percent Change (i.e., reduction) from Baseline to Week 12 in non-inflammatory (open and closed comedones) lesion counts.
次要结局
- The Percentage of Subjects With a Clinical Response (IGA) of "Success" at Week 12(12 weeks)