An Open-label Safety and Tolerability Study of LTS 0.3% With Red Light Applied to the Backs of Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Adverse Events
研究概览
简要总结
The purpose of this study is assess the safety and tolerability of lemuteporfin topical solution (LTS) with exposure to red light (PDT), when applied to the backs of healthy volunteers.
详细描述
This is an open-label, safety study in healthy volunteers. Two cohorts, of 6 subjects each, will be enrolled (total subjects = 12). Each subject will have test areas identified on the back and receive a single LTS, vehicle solution and red light (PDT) applied to the test areas on the back. Subjects will be followed for safety at study visits occurring on Day 1 (baseline and treatment), Day 2, and Day 7.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Healthy adults 18 years of age or older
- •Fitzpatrick skin types I-IV
排除标准
- •Current pregnancy or lactation.
- •Presence of severe facial acne, acne fulminans or conglobata, or nodulocystic acne.
- •Poor skin condition on the back, including erythema, dryness, sunburn, dermatological malignancies, infections, cuts, abrasions, tattoo, excess of hair or any other skin condition
- •Subjects who have used any agents known to produce significant photosensitivity reactions (tetracyclines, phenothiazines, trimethoprim, etc.) within 2 weeks of Day 1 or 5 half-lives, whichever is longer.
- •Subjects who have used any medicated topical therapy on the back within 3 days of Day
- •Chronic treatment with low dose aspirin, a non-steroidal anti inflammatory drug (NSAID), or an anticoagulant regimen such as warfarin (Coumadin).
- •Abnormal findings on screening ECG deemed clinically significant by the Investigator.
- •Active participation in an experimental therapy study or experimental therapy within 30 days of Day
- •Screening clinical chemistry or hematology laboratory value that is considered clinically significant, in the opinion of the Investigator.
- •Subjects who are a poor medical risk because of other systemic diseases or active uncontrolled infections.
研究组 & 干预措施
Red Light (PDT) 150 J/cm2
Subjects in Cohort 2 will receive active and vehicle solution followed by a red light dose of 150 J/cm2 at 40 mW/cm2
干预措施: Red Light (PDT) (Drug)
Red light dose (PDT) 75 J/cm2
Subjects in Cohort 1 will receive active and vehicle solution followed by a red light dose of 75 J/cm2 at 25 mW/cm2
干预措施: Red Light (PDT) (Drug)
结局指标
主要结局
Adverse Events
时间窗: 1 week
Adverse events and local tolerability assessed at pre and immediately post treatment, at Day 1 and Day 7 following treatment.
次要结局
未报告次要终点