The Comparative Efficacy of an Over the Counter Light Therapy Mask vs Over the Counter Topical Benzoyl Peroxide 2.5% and Used in Combination With Over the Counter Adapalene Gel 0.1% for Mild to Moderate Acne
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- change in the Investigator Global Assessment (IGA)
研究概览
简要总结
This is a single-center prospective study of two standard-of-care treatments to evaluate the efficacy of the Neutrogena® Light Therapy Acne Mask an Over the Counter (OTC) Blue/Red light LED mask, as compared to the combination of topical OTC benzoyl peroxide 2.5% gel and OTC adapalene 0.1% gel, for the treatment of mild-to-moderate facial acne. This will be an investigator-blinded, randomized, 12-week study to observe these over the counter treatments. The two arms will be: (1) Neutrogena® Light Therapy Acne Mask (MASK), (2) topical OTC benzoyl peroxide 2.5% gel and OTC adapalene 0.1% gel (TOP). Both treatment groups in this study will also receive and use standardized, non-medicated cleansing and moisturizing products. All products will be purchased through commercial sources.
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 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of acne vulgaris as determined by the study physician
- •Mild-to-moderate acne defined as a grade 2 or 3 on the FDA Investigator Global Acne Assessment (IGA) for Acne vulgaris (Appendix 1)19
- •If female,
- •Negative urine pregnancy test at the time of enrollment and negative urine pregnancy tests at follow up visits
- •Agreement to comply with medically acceptable forms of birth control with heterosexual intercourse
- •Agreement to comply with the study protocol and attend all study visits
排除标准
- •Is unwilling to participate in the survey
- •Outside of specified age range
- •Patients with clear, almost clear acne, or severe acne defined as grade 0-1 or 4 on the IGA Scale
- •Females who are pregnant or breastfeeding
- •Known allergy to any ingredients in the test products or history of photosensitivity
- •Pre-existing facial dermatologic conditions including excoriations that could interfere with the outcome of this study and quantification of acne lesions
- •Excessive facial hair or scarring that could interfere with quantification of acne lesions
- •Does not have decision making capacity
研究组 & 干预措施
Neutrogena ® Light Therapy Acne Mask (MASK)
Over-the-counter powered light-based device for the treatment of acne
干预措施: Neutrogena ® Light Therapy Acne Mask (MASK) (Drug)
Topical benzoyl peroxide 2.5% gel and OTC adapalene
Over-the-counter medication for the treatment of acne + 0.1% Adepalene Gel
干预措施: Topical OTC benzoyl peroxide 2.5% gel and OTC adapalene (Drug)
结局指标
主要结局
change in the Investigator Global Assessment (IGA)
时间窗: 12 Weeks
5 point assessment tool used to measure inflammation caused by acne
次要结局
- change in Acne Q4 quality of life index score(12 Weeks)