CTRI/2022/06/043478尚未招募不适用
To evaluate the invivo safety and efficacy of the skin care formulation in terms of sweat resistance on healthy human subjects
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- sweat resistance, safety
研究概览
简要总结
Objective: The objective of this study is to evaluate the in-vivo safety and efficacyof the skin care formulation in terms of sweat resistance on healthy humansubjects for test product
Kinetics: Day 1 (T0 &T+30 minutes after product application) and Day 2 (T0 & T+30 minutes afterproduct application)
Population: 33 (17 Female & 16 Male) subjects
Theevaluation is performed using:
- Subject Self Evaluation (SSE)
- Dermatological Evaluation: Cosmetic Acceptability
- Tewametry
- Sweat Patch Test
Duration: 2 days following the first application of theproduct.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Indian male & female subjects 2.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.Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….) 4.Being able to produce at least 100 mg of sweat and whose left versus right half face sweat is more or less the same 5.Having shaved beard two days before study visit.
排除标准
- •1.For Females: Being pregnant or breastfeeding or having stopped to breastfeed in the past three months.
- •2.Having refused to give his/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 sensitive or dry skin & acne prone skin.
- •6.Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months) 7.Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products or food products.
- •8.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 (the only medication permitted is paracetamol).
- •9.Having cutaneous hypersensitivity.
- •10.Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
- •11.Having changed her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit.
- •12.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) 13.Refusing to follow the restrictions below during the study:For Females: Do not take part in any family planning activities leading to pregnancy and breastfeeding; Do not take part in another study liable to interfere with this study.; Do not take medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol); Do not change their cosmetic habits apart from the particular conditions mentioned in the protocol, on the studied anatomic unit; Do not have sensitive or dry skin & acne prone skin.; During the study: Do not use other cosmetic products than the tested products to the studied areas.; The day of the measurements: No test product must be used (only face cleaned with water is accepted); The day of the measurements: Do not apply hair oil.
- •14.Having started, changed or interrupted one hormonal treatment (hormonal contraception, Hormone Replacement Therapy) during the past 3 months 15.Having started, changed or stopped his/her tobacco consumption (for smokers consuming more than 10 cigarettes per day) in the previous 6 months 16.Not having shaved beard two days before study visit.
- •17.Having applied oil one day prior study visit.
结局指标
主要结局
sweat resistance, safety
时间窗: Day 1: 30 minutes after product application, Day 2: 30 minutes after product application
次要结局
未报告次要终点
研究者
研究点 (1)
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