CTRI/2023/02/049645已完成未知
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
- 未知
- 状态
- 已完成
- 入组人数
- 35
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1)Indian male and 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)Between 18 and 35 years of age.
- •4)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)
研究者
相似试验
尚未招募
Unknown
Safety and Efficacy check of Cosmetic Product on skiCTRI/2024/01/061433KAYA LIMITED
尚未招募
Unknown
Efficacy check of skin care productCTRI/2023/12/060574SATIYA NUTRACEUTICALS PRIVATE LIMITED
已完成
不适用
Safety and efficacy assessment of Product on skiCTRI/2023/02/049933HONASA CONSUMER PVT LTD. (MAMAEARTH)38
已完成
不适用
Safety & efficacy assessment of products on skiCTRI/2019/08/020708Alembic Pharmaceuticals Ltd34
尚未招募
Unknown
Effect of products on pimplesCTRI/2024/08/072183Richfeel