CTRI/2023/02/049645已完成不适用
To evaluate the in-vivo safety and efficacy of the skin care formulation in terms of non-comedogenic effect on healthy human subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Percent reduction in total number of Comedones
研究概览
简要总结
Objective:
The objective of thisstudy is to evaluate the in-vivo safety and efficacy of the skin careformulation in terms of non-comedogenic effect on healthy humansubjects
Kinetics: T0, T+14 daysand T+28 days
Population: 36 Male andFemales volunteers
The evaluation isperformed using:
1 SubjectSelf Evaluation (SSE) Questionnaire
2 DermatologicalEvaluation: Cosmetic Acceptability
3 DermatologistEvaluation: Efficacy
Duration: 28 days following the firstapplication of the product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 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 (free of eczema, wounds, inflammatory scar….).
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) 15 Having applied hair oil during the entire duration of the study.
- •16 In the previous 6 months -Having started, changed or stopped a hormonal treatment (e.g. hormonal contraception, cyproterone acetate) -Having taken an oral retinoid-based treatment -Having undergone a physical (e.g., phototherapy, laser) or chemical (peeling) treatment for acne 17 In the previous 1 month -Having had a local benzoyl-peroxide-based treatment or a local retinoid-based treatment -Having had an oral treatment with a base of cimetidine, zinc (zinc gluconate) or spironolactone 18 In the previous 2 weeks -Having applied cosmetic products with anti-seborrheic aims or cosmetics for oily skin -Having had oral or local antibiotic treatment for acne 19 In the previous 1 week -Having had beauty treatment (e.g. skin cleansing, exfoliation, scrub, mask) -Having a suntanned skin on the studied areas which could interfere with the evaluations of the study 20 Refusing to follow the restrictions below during the study: -Do not start, change or stop a hormonal treatment (hormonal contraception, cyproterone acetate …) -Do not apply cosmetic products with anti-seborrheic aims or cosmetics for oily skin or for skin with imperfections -Do not have beauty treatment (e.g. skin cleansing, exfoliation, scrub, mask …) -Do not start a local or general treatment acting on seborrhoea -Do not expose to the sun with the intention to sunbathe (activities outside which do not last too much time are authorized).
结局指标
主要结局
Percent reduction in total number of Comedones
时间窗: 14days, 28days
次要结局
未报告次要终点
研究者
研究点 (1)
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