NCT02796066撤回2 期
A Phase 2, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of TSN2898 Topical Gel for the Treatment of Acne Vulgaris
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 6
- 主要终点
- Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
研究概览
简要总结
The purpose of this study is to determine the safety and effectiveness of TSN 2898 topical gel in the treatment of moderate to severe acne.
详细描述
TSN2898 is an inhibitor of stearoyl-CoA desaturase-1 (SCD-1), an enzyme present in sebaceous glands and a key regulatory enzyme in lipogenesis. This study will assess the safety and efficacy of TSN2898 topical gel and matched gel vehicle, applied daily on the face for the treatment of moderate to severe 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 16 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males or females, 16 to 55 years of age
- •Must be diagnosed as having moderate or severe acne vulgaris
- •≥ 20 inflammatory lesions on the face
- •≥ 20 non-inflammatory lesions on the face
- •≤ 3 nodule/cyst acne lesions
- •Medically healthy
- •Females must be of non-childbearing potential
排除标准
- •Systemic therapy with retinoids within six (6) months prior to study start
- •Topical use of prescription retinoids within four (4) weeks prior to study start
- •Oral antibiotics within four (4) weeks prior to study start
- •Topical dapsone, sulfacetamide, benzoyl peroxide, α-hydroxy/glycolic acid and retinol/retinaldehyde-containing products, and topical antibiotics, anti-inflammatory medications and corticosteroids on the face within two (2) weeks prior to study start
- •Facial procedures, including lasers, peels, and dermabrasion, within two (2) months prior to study start
研究组 & 干预措施
Vehicle
Placebo Comparator
Vehicle gel
干预措施: Vehicle (Drug)
Low Dose Active
Experimental
Low Dose of TSN2898
干预措施: TSN2898 (Drug)
Mid Dose Active
Experimental
Mid Dose of TSN2898
干预措施: TSN2898 (Drug)
High Dose Active
Experimental
High Dose of TSN2898
干预措施: TSN2898 (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
时间窗: 12 weeks
次要结局
- Investigator's Global Assessment of Acne Severity Score (IGA)(12 weeks)
- Non-inflammatory lesion counts(12 weeks)
- Absolute change from Baseline for inflammatory plus non-inflammatory lesions(12 weeks)
- Percent change from Baseline for inflammatory and non-inflammatory lesions(12 weeks)
研究者
研究点 (6)
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