A clinical study to evaluate the protective effect of the test product against environmental pollution on the 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 pollution-induced skin damages, based on clinical, instrumental and subjective evaluations done at predetermined time points.
研究概览
简要总结
This is an open label, non-randomized, single-centre, single arm clinical study to evaluate the protective effect of the test product against environmental pollution on the 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 who have lived in high air pollution areas for at least the past 5 years / have been occupationally exposed to high air pollution for the past 2 years.
- •Subjects with visible blackheads on the face.
- •Subjects with at least 2 blemishes, uneven skin tone and visible redness on face.
- •Subjects willing to provide written informed consent to participate in the study.
排除标准
- •Subjects using any other face pack during the study period.
- •Subjects who are receiving topical or systemic treatments for pigmentation within the last 30 days.
- •Subjects having any active dermatological skin diseases (e.g., psoriasis, atopic dermatitis, rosacea etc.), that might interfere with clinical assessments.
- •Subjects participating in other similar cosmetic or therapeutic study within last four weeks.
结局指标
主要结局
To assess the efficacy of test product on pollution-induced skin damages, based on clinical, instrumental and subjective evaluations done at predetermined time points.
时间窗: Day 01, Day 07, Day 14, Day 21 and Day 28.
次要结局
未报告次要终点
研究者
Dr Bhagirath Patel
Cliantha Research