CTRI/2024/01/061433尚未招募不适用
To evaluate the in-vivo safety and efficacy of the skin care formulation in terms of non-comedogenic effect on healthy human subjects
KAYA LIMITED1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2024年1月13日
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Reduction in total number of Comedones
研究概览
简要总结
Objective:
The objective of this study is to evaluate the in-vivo safety and efficacy of the skin care formulation in terms of non-comedogenic effect on healthy human subjects
Kinetics: T0, T+14 days and T+28 days
Population: 36 Male and Females volunteers
The evaluation is performed using:
1 Subject Self Evaluation (SSE) Questionnaire
2 Dermatological Evaluation: Cosmetic Acceptability
3 Dermatologist Evaluation: Efficacy
Duration: 28 days following the first application of the product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Participant 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
- •Indian male and female subjects.
- •Healthy subjects (no infectious and evolutive pathology which could make the subject vulnerable and stop the study, no pathology which could interfere with the study, no symptom in the process of an exploratory checkup) 3)Between 18 and 35 years of age.
- •Skin is healthy on the studied anatomic unit.
排除标准
- •1 Being pregnant or breastfeeding or having stopped to breastfeed in the past three months 2 Having refused to give her assent by not signing the consent form 3 Taking part in another study liable to interfere with this study 4 Being insulin-dependent diabetic or non-insulin-dependent diabetic with a recent therapy (less than 6 months) 5 Having a progressive asthma (either under treatment or last fit in the last 2 years) 6 Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis) 7 Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months) 8 Being epileptic.
- •9 Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, antihistamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol) 10 Having cutaneous hypersensitivity.
- •11 Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
- •12 Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
- •13 Having changed her cosmetic habits except those required by the protocol in the 14 days preceding the start of the study on the studied anatomic unit.
- •14 Having applied a cosmetic product (included make-up) on the studied areas the first day of the study (only face cleaned with water is accepted).
结局指标
主要结局
Reduction in total number of Comedones
时间窗: Baseline,14days, 28days
次要结局
未报告次要终点
研究者
Dr Raji Patil
MASCOT-SPINCONTROL India Pvt. Ltd.
研究点 (1)
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