Randomized, Double-Blind, Cross-Over, Vehicle Controlled Evaluation of Topical Encapsulated Benzoyl Peroxide on the Skin Microbiome and Skin Biophysical Properties
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Change in transepidermal water loss after 8-weeks of treatment compared to baseline.
研究概览
简要总结
The overall objective of this study is to assess how the use of the drug may shift the skin microbiome and skin biophysical properties. Specifically, the study objectives were to assess the following:
- How the drug affects the skin microbiome compared with vehicle when applied once daily for 8 weeks in subjects with papulopustular rosacea.
- How the drug affects the skin physical properties compared with vehicle when applied once daily for 8 weeks in subjects with papulopustular rosacea.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Participants must sign an Institutional Review Board (IRB) approved written informed consent for this study.
- •Male and female 18 years of age and older.
- •Participants must have clinical diagnosis of moderate to severe rosacea.
- •Have a minimum total of 15 and a maximum of 70 total inflammatory lesions (papules and/or pustules) including those present on the nose.
- •Have 2 nodules or less.
排除标准
- •Females, who are pregnant, breastfeeding, or planning a pregnancy within the period of their study participation or were found to have positive pregnancy test at Baseline or screening visits.
- •Presence of more than 2 facial nodules or any nodule greater than 1 centimeter (cm).
- •Current or past ocular rosacea (for example, conjunctivitis, blepharitis, or keratitis) of sufficient severity to require topical or systemic antibiotics.
研究组 & 干预措施
Study Drug
Daily Encapsulated Benzoyl Peroxide (E-BPO) Cream, for 8 weeks (period 1). Subjects will then switch treatments to the vehicle cream for a period of 4 weeks (period 2),
干预措施: Encapsulated Benzoyl Peroxide Cream (Drug)
Vehicle
Daily Vehicle Cream, for 8 weeks (period 1). Subjects will then switch treatments to the study drug encapsulated E-BPO for a period of 4 weeks (period 2),
干预措施: Encapsulated Benzoyl Peroxide Cream (Drug)
结局指标
主要结局
Change in transepidermal water loss after 8-weeks of treatment compared to baseline.
时间窗: 8-weeks
transepidermal water loss in g/m2/h
Change in stratum corneum hydration after 8-weeks of treatment compared to baseline.
时间窗: 8-weeks
stratum corneum water content (wt%)
Change in colorimeter test after 8-weeks of treatment compared to baseline.
时间窗: 8-weeks
facial L\*a\*b\* values
Change in skin microbiome diversity after 8-weeks of treatment compared to baseline
时间窗: 8-weeks
Facial microbiome sampling will be performed on-site by collecting follicular samples as well as utilizing facial swabs.
Change in sebum excretion rate after 8-weeks of treatment compared to baseline.
时间窗: 8-weeks
sebum production in µg/cm2
次要结局
- Change in stratum corneum hydration after 1-week, 2-weeks and 4-weeks of treatment compared to baseline.(4-weeks)
- Change in skin microbiome diversity after 30 minutes, 1-week, 2-weeks and 4-weeks of treatment compared to baseline(4-weeks)
- Change in transepidermal water loss after 1-week, 2-weeks and 4-weeks of treatment compared to baseline.(4-weeks)
- Change in sebum excretion rate after 1-week, 2-weeks and 4-weeks of treatment compared to baseline.(4-weeks)
- Change in colorimeter test after 1-week, 2-weeks and 4-weeks of treatment compared to baseline.(4-weeks)