Open-label, Prospective Study of Skin Balancing Gel Cream Safety and Influence of Skin Microbiome on Acne Prone Skin
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- C. acnes relative abundance
研究概览
简要总结
The purpose of this study is to assess the safety of the skin balancing gel cream and examine the effects it has on the skin microbiome of individuals with non-cystic acne prone skin.
详细描述
Acne, a chronic inflammatory condition, is estimated to affect greater than 85% of the population at some point. It is considered a common skin condition characterized by pimples and occurs when follicles are clogged leading to the formation of acne lesions. In this study, we want to evaluate the impact the skin balancing gel cream has on the skin microbiome on individuals who have mild to moderate non-cystic acne. We will be assessing the changes it has on specific microbiota (Cutibacterium acnes for example) and whether it is tolerated well on acne prone skin.
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 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females between the ages of 18 years of age until 35 years of age
- •Males must be willing to shave facial hair
- •The presence of mild to moderate non-cystic acne based on investigator global assessment
排除标准
- •Individuals who are pregnant or breastfeeding.
- •Prisoners.
- •Adults unable to consent.
- •The presence of severe acne or cysts as noted by the investigator.
- •Those who are unwilling to discontinue topical antibiotics, topical salicylic acid containing products and topical benzoyl peroxide containing products for two weeks to meet the washout criteria prior to enrolling.
- •Those who are unwilling to discontinue all facial topical products except the cleanser and the product provided in the study.
- •Individuals who have been on an oral antibiotic for acne within the previous 1 month.
- •Individuals who have changed any of their hormonal based contraception within
- •months prior to joining the study.
- •Current tobacco smoker or a tobacco smoking history of greater than 10 pack-years.
结局指标
主要结局
C. acnes relative abundance
时间窗: 6 weeks
Shift in the C. acnes relative abundance based on skin microbiome swab collection and sequencing
次要结局
- Functional gene based predictive analysis of skin inflammation related genes(6 weeks)
- Sebum excretion rate(6 weeks)
- Tolerability Assessment Questionnaire(6 weeks)
- Total lesion count(6 weeks)