A Phase 3 Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study of S6G5T-3 in the Treatment of Acne Vulgaris
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 434
- 试验地点
- 1
- 主要终点
- Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 12
研究概览
简要总结
To assess the efficacy of S6G5T-3 compared to its vehicle when applied once daily for 12 weeks in participants with acne vulgaris.
详细描述
In this Phase 3, multi-center, double-blind, randomized, vehicle-controlled, parallel-group pivotal study, participants will be admitted only after a written informed consent has been obtained and after all inclusion/exclusion criteria have been met. Male and female participants at least 9 years of age with facial acne vulgaris will be eligible for enrollment for daily treatment with S6G5T-3 or its vehicle S6G5T-8, for 12 weeks.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 9 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant must sign an Institutional Review Board (IRB) approved written informed consent for this study.
- •Male and female 9 years of age and older.
- •Have 2 or fewer cysts or nodules.
排除标准
- •More than 2 acne nodules or cysts (defined as an inflammatory lesion greater than or equal to 5 millimeter [mm] in diameter).
- •Acne conglobata, acne fulminans and secondary acne (for example, chloracne, drug-induced acne).
- •History of blood dyscrasia (for example, leukemia, haemophilia, sickle cell anemia, multiple myeloma).
- •Underlying disease that requires the use of interfering topical or systemic therapy.
- •Other dermatological conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments such as, but not limited to, atopic dermatitis, perioral dermatitis, or rosacea.
研究组 & 干预措施
S6G5T-3
Participants will topically apply S6G5T-3 cream, once daily to face for 12 weeks
干预措施: S6G5T-3 (Drug)
S6G5T-8 Vehicle Cream
Participants will topically apply S6G5T-8 vehicle cream, once daily to face for 12 weeks.
干预措施: S6G5T-8 (Drug)
结局指标
主要结局
Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 12
时间窗: Baseline, Week 12
Non-inflammatory lesions were characterized by open comedones (blackheads) and closed comedones (whiteheads). Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.
Change From Baseline in Inflammatory Lesion Counts on the Face at Week 12
时间窗: Baseline, Week 12
Inflammatory lesions were characterized by papules, pustules, nodules, and cysts. Least squares means and standard deviations from an analysis of covariance (ANCOVA) with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.
Percentage of Participants Achieving an IGA Score of Clear or Almost Clear and a Score ≥2 Grades Less Than Baseline
时间窗: Baseline through Week 12
Percentage of participants in each treatment group achieving an acne severity IGA score of "clear (score=0)" or "almost clear (score=1)" and achieving an acne severity IGA score of at least 2 grades less than Baseline.
次要结局
- Percent Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 12(Baseline, Week 12)
- Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 8(Baseline, Week 8)
- Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 4(Baseline, Week 4)
- Percent Change From Baseline in Inflammatory Lesion Counts on the Face at Week 12(Baseline, Week 12)
- Percentage of Participants Achieving at Least a 4-Point Reduction on Item 1 (Pimple) of the Patient-Reported Evaluation of Facial Acne (Pre-Face)(Baseline and Week 12)
- Change From Baseline in Inflammatory Lesion Counts on the Face at Week 4(Baseline, Week 4)
- Percentage of Participants Achieving at Least a 4-Point Reduction on Item 5 (Embarrassment) of the Pre-Face(Baseline and Week 12)
- Change From Baseline in Inflammatory Lesion Counts on the Face at Week 8(Baseline, Week 8)