CTRI/2024/10/075272尚未招募不适用
A clinical study to evaluate the anti-blemish efficacy of the test product.
Antonio Puig S A Plaza1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年10月25日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Reduction in skin blemishes (spots, pigmentation, blackheads, PIH, acne, unevenness, scars etc.)
研究概览
简要总结
This study is designed to assess the efficacy of a test product in reducing blemishes in a full face single arm study design. The study will span over 12 weeks where dermatological and instrumental assessments to evaluate change in appearance of skin blemishes, sebum content, glow and radiance, skin colour, safety and tolerability of the test product will be done.
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 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •1 Female subjects in general good health.
- •2 Subjects in the age group 18-35 years both ages inclusive 3 Subjects with blemishes like spots, pigmentation blackheads, PIH, acne, unevenness, scars on the face 4 Subjects willing to give written informed consent and willing to abide by and comply with the study protocol 5 Subjects who have not participated in a similar investigation in past two weeks.
- •6 Subjects willing to refrain from using any other product or home remedies that can impact the skin.
- •7 Subjects who agree not to participate in any other clinical study during participation in the current study.
排除标准
- •1 A known history or present condition of an allergic response/hypersensitivity to any cosmetic or skin pharmaceutical product.
- •2 Subject having active skin diseases like active atopic dermatitis, pigmented contact dermatitis or other cutaneous manifestation, which will interfere with the assessment.
- •3 Female subjects who are pregnant or lactating (Self declared).
- •4 Subjects who have undergone facial treatments in past 4 weeks.
- •5 Subjects on oral medications like topical or systemic corticosteroids, anti fungal, or antibiotics, or any prolonged use of non steroidal anti inflammatory, or anti histaminic within 2 weeks prior to the study, undergoing any chemical treatment-facial or bleach or waxing or which will compromise the study.
- •6 Subjects with any history of underlying uncontrolled medical illness including diabetes mellitus, hypertension, HIV, thyroid, hepatitis, severe anemia, serious disorder of the heart and respiratory apparatus or any other serious medical illness.
- •7 Employees of MSCR or the sponsor.
结局指标
主要结局
Reduction in skin blemishes (spots, pigmentation, blackheads, PIH, acne, unevenness, scars etc.)
时间窗: baseline, Week 2, Week 4, Week 8, Week 12.
次要结局
- 1 Reduction in sebum (sebum control) production after test product usage analyzed by Sebumeter(2 Improvement in facial gloss and radiance after test product usage using Glossymeter.)
研究者
Dr Mukta Sachdev
MS Clinical Research Pvt. Ltd.
研究点 (1)
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