Efficacy of a Handheld Heat Based Device for the Spot Treatment of Mild to Moderate Acne Vulgaris: A Controlled Study to Determine Time to Resolution of Individual Inflammatory Lesions Using an Over-the-counter Acne Heat Device.
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Time to resolution of individual acne lesions
研究概览
简要总结
The aim of our study is to determine the time to resolution of individual acne lesions using a popular handheld heat based device in comparison to no treatment and to standard topical therapy with benzoyl peroxide in order to determine its effectiveness in the spot treatment of acne vulgaris. Patient satisfaction and potential side effects will be examined as well.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 64 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Are 12- 64 years old
- •Have an Investigator's Global Assessment of greater than or equal to 2
- •Have 8-16 inflammatory acne facial lesions (papules and pustules)
排除标准
- •Have any severe facial acne at baseline, including large acne lesions and cysts (nodulocystic acne)
- •Have used any topical anti-acne medications, systemic antibiotics, and/or systemic corticosteroids 4 weeks before the study start
- •Have used oral acne medications, such as Accutane (systemic retinoid), 6 months before the study start
- •Have had a facial procedure 2 weeks before the study start
- •Are nursing or pregnant
- •Are using any oral contraceptives that have a specific anti-androgenic action or if you have started using a new oral contraceptive 12 weeks before the study start
- •Are using any medications known to exacerbate acne
- •Have a known hypersensitivity or allergy to benzoyl peroxide or any of the vehicle constituents
- •Have a beard or facial hair that could interfere with study evaluations
研究组 & 干预措施
Heat based treatment/no treatment
Split face treatment with handheld acne heat based device and no treatment
干预措施: Split face: handheld acne heat based device (Zeno Hot Spot) and no treatment (Device)
Heat based treatment/benzoyl peroxide
Split face treatment with handheld acne heat based device and benzoyl peroxide 4%
干预措施: Split face: handheld acne heat based device, Zeno Hot Spot, and topical benzoyl peroxide 4% (Device)
结局指标
主要结局
Time to resolution of individual acne lesions
时间窗: 5 days
Subjects will be photographed daily and the progression of individual acne lesions will be followed. Time to resolution of each lesion will be determined for the various treatment groups.
次要结局
- Split-face investigator's static global assessment(5 days)
- Device tolerability(5 days)
- Acne lesion counts(5 days)