A clinical study to evaluate the effectiveness of the test product on the tanned skin along with its safety on healthy adult female participants.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 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 instrumental 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 participants.
The potential participants will be screened as per the inclusion and exclusion criteria only after obtaining written informed consent from the participants.
All eligible participants 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
- •Non-pregnant /non-lactating females.
- •Participants with fitzpatrick skin type IV and V.
- •Participants with visible skin tan on face, at least 2 shade darker than a Sun protected upper volar arm.
- •Participants with at least 2 blemishes.
- •Participants who are willing to voluntarily participate in the study and provide signed informed consent.
排除标准
- •Participants with dark facial skin as determined by dermatologist.
- •Participants having any active dermatological skin diseases (e.g., psoriasis, atopic dermatitis, rosacea etc.), that might interfere with clinical assessments.
- •Participants using any other facewash during the study period.
- •Participants using other marketed skin lightening products during the study period or in the past 6 weeks.
- •Participants who are receiving topical or systemic treatments for pigmentation within the last 30 days.
- •Participant undergoing treatment for Seborrhoea, Acne, Dermatitis, Melasma, Lentigines, skin Lightening/ any other cosmetic/ dermatologic skin condition on face.
结局指标
主要结局
To assess the efficacy of test product on tanned skin, based on instrumental evaluations.
时间窗: Day 01 (Before and after product usage) , Day 03, Day 07, Day 14 and Day 21.
次要结局
- To assess the efficacy of test product on tanned skin, based on clinical, instrumental and subjective evaluations.(Day 01 (Before and after product usage) , Day 03, Day 07, Day 14 and Day 21.)
研究者
Dr Bhagirath Patel
Cliantha Research