Double Blinded, Split Face Investigation of the Tolerability of Two Facial Cleansing Routines for Mild to Moderate Acne
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Change in IGA Score between Geologie and ProActiv daily treatment
研究概览
简要总结
The objective of this study is to compare tolerability of two similar commercially available over the counter acne regimens (Geologie and Proactiv) in individuals with mild to moderate acne vulgaris over a 12-week daily treatment course.
详细描述
Acne vulgaris is a common, chronic inflammatory skin disorder that originates in the pilosebaceous unit. Acne typically begins in adolescence and often continues into adulthood, with about 20% of cases resulting in scars or hyperpigmentation. It's estimated that acne affects about 85% of adolescents. Individuals who experience acne and acne scars tend to also experience a negative impact on their social and mental health, including depression, anxiety, and social withdrawal. Currently, topical solutions and lifestyle changes are the primary treatment for mild to moderate acne.
This study will evaluate and compare the efficacy of two over the counter products in treating individuals with mild to moderate acne: Geologie and ProActive. Both sets of products will be provided to Northwestern in identical, unlabeled bottles for the purpose of blinding.
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
盲法说明
All sets of products will be provided to Northwestern in identical, unlabeled bottles for the purpose of blinding.
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
- •18 years or older
- •No known active skin infection.
- •Presence of mild or moderate acne on face (clinical diagnosis or self-report)
- •Willingness to give written consent and comply with study procedures.
排除标准
- •Active skin infection.
- •Inability to understand instructions or procedures involved.
- •Known allergy to ingredient(s) in products being used for study.
- •Pregnant women, prisoners, and vulnerable populations.
- •Has a history of acute or chronic disease that may interfere with or increase the risk of study participation.
- •Has any dermatological disorder that may interfere with the accurate evaluation of the subject's facial appearance, based on the opinion of the investigator.
研究组 & 干预措施
Acne Treatment
干预措施: Geologie Acne Regimen - one side of face (Combination Product)
Acne Treatment
干预措施: Proactive Acne Regimen - other side of face (Combination Product)
结局指标
主要结局
Change in IGA Score between Geologie and ProActiv daily treatment
时间窗: 12 weeks
Investigator Global Assessment (IGA) will be collected on a scale of 0-4 with 0 being clear and 4 being severe.
次要结局
未报告次要终点
研究者
Stephanie Rangel
Principal Investigator
Northwestern University