To evaluate the in vivo safety and efficacy of skin care formulations in terms of reduction in acne on healthy human subjects
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Reduction in acne
研究概览
简要总结
OBJECTIVE-The objective of this study will be to evaluate the in-vivo safety and efficacyof a skin care formulation in terms of reduction in acne on healthy human subjectsThe evaluation is performed using- Subject Self Evaluation(SSE) , Dermatological Evaluation:Cosmetic Acceptability, Dermatological Evaluation: Efficacy, Images of whole face under Diffused Light
POPULATION-66 female & male subjects will be selected for the study. The study will beconducted in 2 groups and 33 subjects in each group.Group A - Product A
Group B - Product B
The subjects selected for this study are healthymale and female, aged between 18 and 30 years,presenting mild to moderateacne and oily to mixed oily skin type.
STUDY DURATION-14 days following the first use of the product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 30.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Indian Male and Female subjects 2.Healthy subjects 3.Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….) 4.Having mild to moderate acne.
- •5.Having mixed oily or oily skin type.
排除标准
- •for female-Being pregnant or breastfeeding or having stopped to breastfeed in the past three months.
- •Having refused to give his/her assent by not signing the consent form and Informed consent form
- •Taking part in another study liable to interfere with this study
- •Being known diabetic case
- •Known asthma case
- •Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis)
- •Being known thyroid case
- •Being epileptic.
- •Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy, taken by general or local routes or corticosteroid by any route (the only medication permitted is paracetamol)
- •Known case of hypersensitivity.
- •Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
结局指标
主要结局
Reduction in acne
时间窗: Baseline , Day 14
次要结局
未报告次要终点