Intralesional Injections of Triamcinolone for Acne Vulgaris
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Safety of intralesional triamcinolone injection
研究概览
简要总结
This proof-of-concept study seeks to investigate the safety of intralesional injections of triamcinolone for acne vulgaris lesions using an Intradermal Needle Adapter.
详细描述
This is an open-label, prospective, single-arm study. Approximately 20 subjects will be enrolled at 1 study site.
All subjects will receive treatment with the study protocol (i.e., intralesional injection with triamcinolone) at Visit 1 (Day 1). Subjects will then attend in-clinic visits at Visit 2 (24-hours post-injection), Visit 3 (48-hours post-injection), Visit 4 (72-hours post-injection), Visit 5 (Day 7), and Visit 6 (Day 14).
Efficacy assessments (target lesion assessments, photography) and safety assessments will be conducted by the Investigator at each study visit. Subjects will conduct lesion pain assessments at each study visit as well as satisfaction assessments at each post-treatment visit.
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 urine pregnancy test at Baseline.
- •Diagnosed with facial acne vulgaris.
- •At least one (1) identifiable inflammatory lesion that, in the opinion of the investigator, is amenable to intralesional injection of triamcinolone.
- •Able to follow study instructions and likely to complete all required visits.
- •In good general health as determined by medical history at the time of screening (Investigator discretion).
- •Sign the IRB-approved informed consent form (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).
- •Planning to move out of the area prior to study completion.
- •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.
研究组 & 干预措施
Treatment group
Participants will receive injections of 1% triamcinolone into at least 1 and up to 3 facial inflammatory acne lesions. Participants will return to clinic at 24, 48, 72 hours, 7 days, and 14 days following injection for follow up assessment and photography.
干预措施: Triamcinolone Injection (Drug)
结局指标
主要结局
Safety of intralesional triamcinolone injection
时间窗: 14 days
Adverse events and changes in concomitant medications
次要结局
- Target Lesion Erythema(14 days)
- Target Lesion Severity(14 days)
- Target Lesion Improvement(14 days)
- Target Lesion Pain(14 days)
- Target Lesion Injection Pain(Immediately after the injection of the first target lesion and at 5 minutes post-injection)