Patient Self-Administered Intralesional Injections of Triamcinolone for Acne Vulgaris
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 5
- 主要终点
- Incidence of adverse events following device use
研究概览
简要总结
The goal of this clinical trial is to test the safety of intralesional injections of triamcinolone self-administered into acne lesions via an injection assistance device. The main question[s] it aims to answer are:
- is use of the injection assistance device safe?
- is delivery of triamcinolone to acne lesions via the injection assistance device efficacious?
Participants will self-inject low dose triamcinolone into acne lesions and track lesion response via photos and survey for 14 days following injection.
详细描述
This is an open-label, prospective, single-arm study. Approximately 150 subjects will be enrolled at approximately 3 study sites.
All subjects will receive standard-of-care intralesional injection with triamcinolone using an Injection Assistance Device (i.e., for self-administered intralesional injections) at Visit 1 (Day 1). Subjects will then submit photos via secure photographic app for asynchronous follow up on Day 2 (24-hours post-injection), Day 3 (48-hours post-injection), Day 4 (72-hours post-injection), Day 7, and Day 14.
Efficacy assessments (target lesion assessments) will be conducted remotely by the Investigator at time of each photo submission. Subjects will conduct lesion pain assessments and satisfaction assessments at the time of each remote check-in. Participants will be invited to also have additional photography captured by the study team at the study site or at a location as per participants' convenience.
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
- 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
- 否
入选标准
- •Outpatient, male or female of any race, 18 years of age or older. Female subjects of childbearing potential must have a negative UPT at Baseline.
- •Diagnosed with facial acne vulgaris.
- •At least one (1) identifiable inflammatory lesion that, in the opinion of the investigator, is clinically indicated for standard-of-care intralesional injection(s) of triamcinolone.
- •Owner of smartphone with capacity for front-facing photography and app download from Apple App Store or Google Play.
- •Able to follow study instructions and likely to comply with virtual follow-up requirements.
- •In good general health as determined by medical history at the time of screening (Investigator discretion).
- •Sign the IRB-approved ICF (including HIPAA authorization) prior to any study-related procedures being performed.
排除标准
- •Female subjects who are pregnant or breast-feeding.
- •Known hypersensitivity or previous allergic reaction to any constituent of triamcinolone injection.
- •Active cutaneous viral infection in any treatment area at Baseline.
- •Have concomitant skin disease or infection (other than acne) or presence of skin comorbidities in the areas of skin where study device will be used.
- •History of poor cooperation or unreliability (Investigator discretion).
- •Subjects who are investigational site staff members or family members of such employees.
- •Exposure to any other investigational device within 30 days prior to Visit 1.
结局指标
主要结局
Incidence of adverse events following device use
时间窗: 14 days
Adverse events associated with device use for 14 days following injection
次要结局
- Subject satisfaction or dissatisfaction with treatment assessed via a 5-grade scale(24 hours - 14 days)
- Target Lesion Pain(14 days)
- Target Lesion Change (subject)(24 hours - 14 days)
- Target Lesion Severity(baseline - 14 days)
- Target Lesion Erythema(baseline - 14 days)
- Target Lesion Injection Pain(baseline and 5 min following injection)
- Target Lesion Change(24 hours - 14 days)