CTRI/2025/08/093326尚未招募Unknown
A Single Arm clinical study to evaluate the Anti-Acne activity of Spot Corrector Gel Cream
Krauter Healthcare Ltd.1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2025年9月1日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- 1. Change in Sebum
研究概览
简要总结
A single blind one arm study.
Each participant entering the trial will be assigned to a regimen of investigational product with the below assessments.
Product is applied on half of the face, and no product is applied on the other half, with sebum assessment at different timepoints to study the comparative reduction in sebum production.
Assessment
-
Sebum by Sebumeter
-
Lesion Counts
-
IGA Evaluation 5- or 6-point scale (clear to severe).
Assessment Time: T0min, T+3 Days, T+7 Days
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female, 18–50 years, able to give informed consent (parental consent if minor per local regulations).
- •Mild to moderate acne vulgaris as defined above.
- •Fitzpatrick skin types I–VI allowed.
- •Willing to comply with study procedures and avoid new topical acne treatments during study.
- •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.
- •Use of systemic acne medications (e.g., oral isotretinoin within past 6 months) or topical prescription acne medications within 4 weeks.
- •Significant dermatologic conditions other than acne that could interfere with assessments.
- •Known sensitivity to product ingredients.
- •Recent facial procedures (chemical peels, lasers) within 4 weeks.
- •Have participated in any interventional clinical trial in the previous 90 days.
- •Have a known sensitivity to any of the constituents of the test product
- •Have not skin related issues.
结局指标
主要结局
1. Change in Sebum
时间窗: At Day1 T0, Day3, Day7
2. Change in lesion counts
时间窗: At Day1 T0, Day3, Day7
3. DSLR Imaging
时间窗: At Day1 T0, Day3, Day7
次要结局
- Not Applicable(Not Applicable)
研究者
Dr Robin Chugh
CCFT Laboratories
研究点 (1)
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