A Single Center, Phase 4, Open-label Prospective Case Series Study of the Safety and Efficacy of Sarecycline for 12 Weeks in Subjects Ages 9 and Over With Truncal Acne
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change from Baseline in Acne Severity Based on Investigator's Global Assessment Success
研究概览
简要总结
The purpose of this study is to determine the efficacy and safety of oral sarecycline 1.5 mg/kg/day in truncal acne. Patients with moderate to severe acne vulgaris will be observed over a period of 12 weeks. Lesion counts, investigator's global assessments, photography, and safety measures will be assessed for the trunk and face.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 9 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female age 9 or above.
- •Clinical diagnosis of moderate to severe truncal acne based on IGA
排除标准
- •Known or suspected allergies or sensitivities to any components of the study drug.
- •Any disorders that would preclude the use of tetracycline-class antibiotics or sarecycline.
- •Any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with the interpretation of the trial results and/or put the subject at significant risk (according to the Investigator's judgment) if the subject takes part in the trial.
- •Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Sarecycline
Eligible patients will be prescribed with commercially available sarecycline at a dosage of 1.5 mg/kg/day and followed for 12 weeks post initiation of treatment.
干预措施: Sarecycline (Drug)
结局指标
主要结局
Change from Baseline in Acne Severity Based on Investigator's Global Assessment Success
时间窗: Baseline, Week 12
Investigator's Global Assessment (IGA) success for truncal acne vulgaris at week 12
Change from Baseline in Absolute Lesion Count
时间窗: Baseline, Week 12
Absolute change from baseline lesion counts for inflammatory acne for truncal acne vulgaris at week 12
次要结局
- Adverse Events and Adverse Events of Special Interest(Baseline, Week 12)
研究者
Angela Moore
Principal Investigator
Arlington Research Center