NCT05271487Unknown不适用
The Effects of a Botanical Skin Care Regimen on Mild to Moderate Acne and the Microbiome
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Total lesion count
研究概览
简要总结
The purpose of this study is to analyze changes in acne and changes in the gut and skin microbiome with the use of a multi-step botanical skin care regimen in those with mild to moderate acne.
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
- 15 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects 15 years of age until 45 years of age.
- •The presence of mild to moderate acne based on investigator global assessment.
排除标准
- •The presence of severe acne as noted by the investigator global assessment.
- •Those with a nut allergy.
- •Those who are unwilling to discontinue oral probiotic-based supplementation to meet the washout criteria prior to enrolling.
- •Those who are unwilling to discontinue topical antibiotics and topical benzoyl peroxide to meet the washout criteria prior to enrolling.
- •Individuals who are unwilling to discontinue vitamin E containing supplements during the washout and intervention.
- •Individuals who have been on an oral antibiotic for acne within the previous 1 month.
- •Individuals who are pregnant or breastfeeding.
- •Individuals who have changed any of their hormonal based contraception within 3 months prior to joining the study.
- •Oral supplementation that has nuts in it.
- •Use of isotretinoin within the three 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
Total lesion count
时间窗: 8 weeks
Number of of inflammatory lesions, and open and closed comedones
次要结局
- Sebum excretion(8 weeks)
- Investigator global assessment (IGA) of acne(8 weeks)
- Gut microbiome assessment(8 weeks)
- Inflammatory lesion count(8 weeks)
- Non-inflammatory lesion count(8 weeks)
- Skin microbiome diversity(8 weeks)
- Positive and Negative Affect Schedule (PANAS-SF)(8 weeks)
- Diurnal Cortisol Slope(8 weeks)
- Salivary Sex Hormone Levels(8 weeks)
研究者
Raja Sivamani, MD MS AP
Principal Investigator
Integrative Skin Science and Research
研究点 (2)
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