CTRI/2023/02/049828已完成未知
Primary objectiveTo evaluate the in-vivo efficacy and safety of a skin care formulation in terms of reduction in Acne(lesion size & redness) and reduction in Acne PIH dark spots on healthy human subjects.secondary objectiveTo evaluate the in-vivo safety and efficacy of a skin care formulation in terms of sebum reduction,visible reduction in appearance of pore size & skin smoothness on healthy human subjects.
Kama Ayurveda Pvt Ltd0 个研究点目标入组 36 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 36
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 16 and 30 years of age.
- •4.Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….)
- •Having oily skin & combination skin on the face.
- •5.Having acne prone skin.
- •6.Having visible pores.
- •7.Having mild to severe acne.
- •8.Having acne PIH spots.
排除标准
- •1.For female, being pregnant or breastfeeding or having stopped to breastfeed in the past three months
- •2. Having refused to give her/his 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, anti-histamines, 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/his 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.Refusing to follow the restrictions below during the study:
- •- For female: 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 her/his cosmetic habits apart from the particular conditions mentioned in the protocol, on the studied anatomic unit.
- •- During the study: Do not use other cosmetic products than the tested product to the studied areas (only the usual cleanser and make-up for the lips and eyes are accepted)
- •- During the study: Do not use hair oil
- •- The day of the measurements: No test product must be used (only face cleaned with water is accepted)
研究者
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