Phase 1/2 Study of Photodynamic Therapy (PDT) With Lemuteporfin Topical Solution (LTS) in Healthy Volunteers and in Subjects With Mild Acne
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 1
- 主要终点
- Change in sebum excretion rate
研究概览
简要总结
The purpose of this study is to determine the safety of photodynamic therapy (PDT) with lemuteporfin topical solution (LTS) in healthy subjects and subjects with mild acne.
详细描述
This is a sequentially staged (Stage 1-4), proof of concept study assessing the safety of photodynamic therapy (PDT) and lemuteporfin topical solution (LTS) in healthy subjects and subjects with mild acne. Approximately 12 subjects will be enrolled in Stage 1 in order to determine a maximum tolerated light dose following LTS application. Up to 90 subjects with mild acne will be enrolled in Stage 2 in order to assess the safety of PDT following a single LTS application. Up to 50 subjects will be enrolled in Stage 3 in order to assess the safety of PDT following repeat LTS applications. Up to 40 subjects will be enrolled into Stage 4 to assess multiple treatments of LTS-PDT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Stage 1 only: healthy subjects
- •Stage 1-4: male or female subjects age 18 years or older
- •Stage 2: subjects with sebum excretion rate of 4 or higher on forehead
- •Stage 2-4: subjects with at least 2 inflammatory acne lesions on the forehead
- •Stage 3-4: subjects with sebum excretion rate of 5 or higher on forehead
排除标准
- •Poor skin condition on back (Stage 1) or face (Stage 2 & 3)
- •Severe facial acne, acne fluminans/conglobata, or nodulocystic acne
- •Stage 2-4: previous use of Diane-35 within 6 months of Day 0, systemic acne treatment or systemic antibiotic treatment within 28 days of Day 0, topical acne treatment to the face within 14days of Day 0 or PDT to the face within 3 months of Day 0
- •Stage 2-4: previous treatment of isotretinoin or other oral retinoids
研究组 & 干预措施
LTS/Vehicle
Within subject control study
干预措施: Lemuteporfin (Drug)
结局指标
主要结局
Change in sebum excretion rate
时间窗: Baseline to Day 14
次要结局
- Change in acne lesion count(Baseline to Day 14)
- Change in biomarkers (e.g., caspase-3, CD163, neutrophil elastase)(Baseline to Day 14)