A Clinical Study to Evaluate the Non-Comedogenic Effect of Saundarym Carrot Face & Body Moisturiser
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- 1. Change in Comedone count (Retentional lessons)
研究概览
简要总结
A single blind one arm study.
Subjects must have not more than 25 facial lesions, which are predominately open and closed comedones. A board-certified dermatologist evaluates the lesions on the face and the results are recorded.
Typically, the subject uses the test material on the face for 4 weeks. For a 4-week trial, evaluations occur after 2 weeks (optional) and 4 weeks of test material use.
A board-certified dermatologist evaluates the lesions on the face and the results are recorded. Differences between baseline and interim or final evaluations are considered statistically significant if the probability of obtaining the results by chance is ≤0.050 using analysis of variance and/or 1-test statistical analysis.
Assessment: Count of number of retentional lesions[Comedones] (closed comedones and opened comedones) and/or inflammatory lesions (papules, pustules and excoriated lesions)
Assessment Time: Day0, Day14, Day28
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
入选标准
- •Gender: Male or Female with age 18-45 2)Having oily or mixed oily skin on the face.
- •Subjects willing to give written informed consent 4)Women of child bearing potential must have a negative urine pregnancy test prior to study entry.
- •Are free of any systemic or dermatologic disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk of adverse events.
- •Are willing to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural or artificial) for the duration of the study.
排除标准
- •Subjects who are pregnant, breast-feeding, or planning to become pregnant during the study.
- •Have any evidence of systemic cancer, squamous cell carcinoma, basal cell carcinoma, in the last 5 years, or any other confounding skin condition.
- •Have any condition that, in the opinion of the investigator, would confound the safety and/or efficacy assessments of the product.
- •Have participated in any interventional clinical trial in the previous 30 days.
- •Have a known sensitivity to any of the constituents of the test product including sensitivities to the test product ingredients
- •Have used, are using, or are planning to use immunosuppressive or immunomodulatory medication (i.e., biologics), including corticosteroids.
- •Having applied hair oil during the entire duration of the study
- •No Chronic illness.
结局指标
主要结局
1. Change in Comedone count (Retentional lessons)
时间窗: At t0, t+14days, t+28days
2. Change in inflammatory lessons
时间窗: At t0, t+14days, t+28days
次要结局
- Not Applicable(Not Applicable)
研究者
Dr Robin Chugh
CCFT Laboratories