CTRI/2023/02/049933已完成未知
To evaluate the in-vivo safety and efficacy of the skin care formulation in terms of reduction in acne severity, reduction in sebum and Acne PIH spot on healthy female &male subjects.
HONASA CONSUMER PVT LTD. (MAMAEARTH)0 个研究点目标入组 38 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
- 38
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
- •The study will be conducted on subjects who will fulfill the following criteria:
- •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 30 years of age.
- •4.Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory
- •5.Having mild to moderate acne.
- •6.Having mixed oily or oily skin on the face.
- •7.Having acne PIH dark spot (with at least one dark spot >3.5 mm in diameter).
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 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
- •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:
- •-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)
- •-For males, having not shaved their beard 24 hours prior to the day of measurement.
- •17.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
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