NCT06425900进行中（未招募）4 期
Histologic and Liquid Chromatography Mass Spectrometry (LCMS) Evaluation of the Sebaceous Gland Changes Induced by Clascoterone Cream 1%
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- The primary efficacy endpoint is the histologic demonstration of reduced facial sebaceous gland size when comparing baseline to 3 months of clascoterone cream 1 % treatment.
研究概览
简要总结
to compare facial sebaceous gland morphology after 3 months of clascoterone cream 1% treatment and to compare facial sebum constituents at baseline to facial sebum constituents after 3 months of clascoterone cream 1% treatment
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
- 否
入选标准
- •Female or male subjects age 18-35 years.
- •Subjects of all Fitzpatrick skin types.
- •Subjects with moderate facial acne and prominent pores indicating sebaceous gland activity.
- •Subjects with oily facial skin.
- •Subjects who agree to use only the study product and nothing else to the face.
- •Subject must possess no scars or tattoos or other confounding dermatologic conditions on the face in the preauricular biopsy sites on the left and right face.
- •Subjects agree not to introduce any new skin care products during the study.
- •No known medical conditions that, in the investigator's opinion, may interfere with study participation.
- •Subjects have signed an Informed Consent Form in compliance with 21CFR Part 50: "Protection of Human Subjects."
- •Subjects are dependable and able to follow directions and willing to comply with the schedule of visits.
- •Subjects in generally good physical and mental health.
排除标准
- •Any dermatological disorder, which in the investigator's opinion, may interfere with the accurate evaluation of the subject's skin characteristics.
- •Subjects who are not willing to use the assigned study product to their face as instructed.
- •Subjects who have used any topical prescription products on the face for 4 weeks prior to study entry.
- •Subjects who have used any OTC products on the face for 2 weeks.
- •Subjects with clinically significant unstable medical disorders.
- •Subjects who are unwilling or unable to comply with the requirements of the protocol.
- •Subjects who have history of a psychological illness or condition that would interfere with their ability to understand and follow the requirements of the study.
- •Subjects currently participating in any other clinical trial.
研究组 & 干预措施
Winlevi (Clascoterone ) cream 1%
Experimental
干预措施: Winlevi (Clascoterone) cream 1% (Drug)
结局指标
主要结局
The primary efficacy endpoint is the histologic demonstration of reduced facial sebaceous gland size when comparing baseline to 3 months of clascoterone cream 1 % treatment.
时间窗: Week 12
次要结局
- The secondary efficacy endpoint is the changes in sebum composition when comparing baseline to 3 months of clascoterone cream 1 % treatment.(Week 12)
研究者
研究点 (1)
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