NCT04059523已完成1 期
A Phase 1b, Multicenter, Open-Label, Parallel-Group, Maximal Use Systemic Exposure (MUSE) Study to Evaluate the Pharmacokinetics, Safety and Tolerability of S6G5T-3 Compared to Retin-A® 0.1% in Subjects With Moderate to Severe Acne Vulgaris
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Pharmacokinetics of S6G5T-3 as measured by the maximum observed plasma concentration
研究概览
简要总结
To assess the degree of systemic exposure of S6G5T-3 compared to the Reference Listed Drug (RLD) Retin-A® 0.1% Cream when applied topically once daily for 14 days, under maximal use conditions in adolescents ≥12 years of age and adults with 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
- None
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
- •Male and female subjects 9 years of age or older.
- •Subject must consent to participate, verified by signing an approved written Informed Consent Form (ICF).
- •Subjects must be generally healthy and free from any clinically significant disease, other than acne vulgaris, that might interfere with the study evaluations
- •All females of child-bearing potential and premenarchal, excluding women who are surgically sterile
排除标准
- •Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne etc.) or severe acne requiring systemic treatment.
- •Underlying disease which requires the use of topical or systemic therapy which may confound study results or make results difficult to interpret.;
- •Subjects unable to communicate well with the site study team (i.e., language problem, poor mental development or impaired cerebral function).
- •Any other factor that, in the opinion of the Investigator, would prevent the subject from complying with the requirements of the protocol.
研究组 & 干预措施
S6G5T-3
Experimental
topical cream
干预措施: S6G5T-3 (Drug)
Retin-A® 0.1% Cream
Active Comparator
topical cream
干预措施: Retin-A® 0.1% Cream (Drug)
结局指标
主要结局
Pharmacokinetics of S6G5T-3 as measured by the maximum observed plasma concentration
时间窗: 14 days
The degree of systemic exposure of S6G5T-3 compared to the Reference Listed Drug (RLD) when applied topically once daily for 14 days, under maximal use conditions in subjects with acne vulgaris. Cmax = Maximum plasma concentration will be calculated
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
终止
不适用
Bioavailability Study of Folate in Healthy SubjectsHealthyNCT05699473Lesaffre International12
已完成
3 期
Study of ProMetic BioTherapeutics Immune Globulin Intravenous (Human) 10%Primary ImmunodeficiencyNCT02269163Prometic Biotherapeutics, Inc.82
终止
1 期
Study of the Safety and Efficacy of MIW815 With PDR001 in Patients With Advanced/Metastatic Solid Tumors or LymphomasSolid Tumors and LymphomasNCT03172936Novartis Pharmaceuticals106
已完成
1 期
Dose Escalation of RMC-5552 Monotherapy in Relapsed/Refractory Solid TumorsSolid TumorsNCT04774952Revolution Medicines, Inc.58
已完成
1 期
Acute Safety, Tolerability, Feasibility and Pharmacokinetics of Intrath. Administered ATI355 in Patients With Acute SCIAcute Spinal Cord InjuryNCT00406016Novartis52