Efficacy and Safety of Topical Clascoterone Cream 1% in Patients With Facial Acneiform Rosacea
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Biopsy proven reduction in size of sebaceous glands at the end of 12 weeks of treatment compared to the baseline.
研究概览
简要总结
To demonstrate the efficacy of Clascoterone cream 1% in reducing the size of sebaceous glands in study participants with acneiform rosacea.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women ages 18+.
- •Diagnosis of rosacea type 2 (papulopustular).
- •Available and willing to comply with study instructions and attend all study visits.
- •Able and willing to provide written and verbal informed consent.
- •Subject has used the same type and brand of make-up, other facial products, and hair products (e.g., shampoo, gel, hair spray, mousse, etc.) for at least one month prior to the baseline visit and agrees to continue his/her other general skin and hair care products and regimen for the entire study.
排除标准
- •Subject has any skin pathology or condition that could interfere with the evaluation of the test products or requires the use of interfering topical or systemic therapy.
- •Subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
- •Pregnant, lactating, or is planning to become pregnant during the study.
- •Subject is currently enrolled in an investigational drug or device study.
- •Subject has received an investigational drug or has been treated with an investigational device within 30 days prior to the initiation of treatment (baseline).
- •Study participant has facial hair that could interfere with the study assessments in the opinion of the investigator.
- •Study participant is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function.
- •Subject has known hypersensitivity or previous allergic reaction to any of the active or inactive components of the test articles.
- •Subject has the need or plans to be exposed to artificial tanning devices or excessive sunlight during the trial.
研究组 & 干预措施
Patients with Acneiform or Papulopustular Rosacea
Patients with diagnosis of papulopustular or acneiform rosacea
干预措施: Clascoterone Cream 1% (Drug)
结局指标
主要结局
Biopsy proven reduction in size of sebaceous glands at the end of 12 weeks of treatment compared to the baseline.
时间窗: From enrollment to end of treatment at 12 weeks
We will perform both a paired and pooled statistical analysis. We will conduct a power analysis to determine statistical significance. For the paired analysis, we will calculate the average gland size per patient at baseline and again at the end of the treatment period from all the individual's biopsy sites. We will then calculate the percent reduction of sebaceous gland size between the two average sizes. Finally, we will calculate the average percent change across all participants. For the pooled analysis, we will calculate the average sebaceous gland size across all study participants before and after treatment. We will use these two values to calculate the percent change. We anticipate that the paired analysis will yield more meaningful results as the pooled analysis may not show significant change due to the variations between study participants used to calculate the averages.
次要结局
- Evaluation of safety and adverse events(From enrollment to end of treatment at 12 weeks)
- Pre- and post-treatment digital photography with a camera (Canfield Scientific, Parsippany, NJ) to depict clinical improvement of rosacea.(From enrollment to end of treatment at 12 weeks)
- Physician and study participants reported assessments at the end of the treatment compared to baseline(From enrollment to end of treatment at 12 weeks)