A Phase 3 Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study of S5G4T-1 in the Treatment of Papulopustular Rosacea
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 372
- 试验地点
- 1
- 主要终点
- Percentage of Participants Achieving an IGA Score of Clear or Almost Clear From Baseline at Week 12
研究概览
简要总结
To assess the efficacy and safety of S5G4T-1 compared to S5G4T-1 vehicle when applied once daily for 12 weeks in participants with papulopustular rosacea.
详细描述
In this Phase 3, 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 18 years of age with moderate or severe papulopustular rosacea will be eligible for enrollment for daily treatment with S5G4T-1 or its vehicle 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must sign an Institutional Review Board (IRB) approved written informed consent for this study.
- •Male and female 18 years of age and older.
- •Participants must have clinical diagnosis of moderate to severe rosacea.
- •Have a minimum total of 15 and a maximum of 70 total inflammatory lesions (papules and/or pustules) including those present on the nose.
- •Have 2 nodules or less.
排除标准
- •Females, who are pregnant, breastfeeding, or planning a pregnancy within the period of their study participation or were found to have positive pregnancy test at Baseline or screening visits.
- •Presence of more than 2 facial nodules or any nodule greater than 1 centimeter (cm).
- •Current or past ocular rosacea (for example, conjunctivitis, blepharitis, or keratitis) of sufficient severity to require topical or systemic antibiotics.
研究组 & 干预措施
S5G4T-1
Participants will topically apply S5G4T-1 cream, once daily to face for 12 weeks.
干预措施: S5G4T-1 (Drug)
S5G4T-2 Vehicle Cream
Participants will topically apply S5G4T-2 vehicle cream, once daily to face for 12 weeks.
干预措施: S5G4T-2 (Drug)
结局指标
主要结局
Percentage of Participants Achieving an IGA Score of Clear or Almost Clear From Baseline at Week 12
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)". Please note, the Percentage of Participants multiplied by the Overall Number of Participants Analyzed does not equal a whole number because missing efficacy data was based on estimation using the method of Markov Chain Monte Carlo (MCMC) imputation.
Change From Baseline in Inflammatory Lesion Counts at Week 12
时间窗: Baseline, Week 12
Inflammatory lesions were characterized as papules and pustules. A papule was defined as a solid, elevated inflammatory lesion equal to or less than 5 mm in diameter. A pustule was defined as an elevated inflammatory lesion equal to or less than 5 mm in diameter and contains pus (yellow-white exudate). Least squares means and standard deviations from an analysis of covariance (ANCOVA) with factors of treatment, analysis center and treatment by analysis center interaction and the Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.
次要结局
- Percent Change From Baseline in Inflammatory Lesion Counts at Week 12(Baseline, Week 12)