A clinical study to evaluate the effectiveness of the test product on the tanned skin along with its safety on healthy adult female subjects.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- To assess the efficacy of test product on tanned skin, based on clinical, instrumental and subjective evaluations
研究概览
简要总结
This is an open label, non-randomized, single-center, single-arm clinical study to evaluate the effectiveness of the test product on the tanned skin along with its safety on healthy adult female subjects.
The potential subjects will be screened as per the inclusion and exclusion criteria only after obtaining written informed consent from the subjects.
All eligible subjects will undergo clinical evaluation by a Dermatologist, instrument evaluation and subjective evaluation. Safety will be assessed throughout the study by monitoring adverse events.
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 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Subjects with fitzpatrick skin type IV and V.
- •Subjects with visible skin tan on face, at least 2 shade darker than a Sun protected upper volar arm.
- •Subjects with at least 2 dark spots / blemishes.
- •Subjects willing to provide written informed consent to participate in the study.
排除标准
- •Subjects with dark facial skin as determined by dermatologist.
- •Subjects who are receiving topical or systemic treatments for pigmentation within the last 30 days.
- •Subjects using other marketed skin lightening products during the study period or in the past 6 weeks.
- •Subjects using any other night cream during the study period.
结局指标
主要结局
To assess the efficacy of test product on tanned skin, based on clinical, instrumental and subjective evaluations
时间窗: Day 01, Day 03, Day 07, Day 14 and Day 28.
次要结局
未报告次要终点
研究者
Dr Bhagirath Patel
Cliantha Research