To evaluate the in vivo safety and efficacy of a Tranexamic Acid formulation in reducing hyperpigmentation in terms of Acne PIH and uneven skin tone on healthy human subjects
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Reduction of hyperpigmentation and uneven skin tone
研究概览
简要总结
OBJECTIVE
The objective of this study will be to evaluate the in vivo safety and efficacy of a Tranexamic Acid formulation in reducing hyperpigmentation in terms of Acne PIH and uneven skin tone on healthy human subjects
The evaluation is performed using:Subject Self Evaluation, Dermatological Evaluation: Cosmetic Acceptability, Dermatological Evaluation: Efficacy, Mexametry
POPULATION : 36 (18 females and 18 males) healthy subjects are selected for the study.
The subjects selected for this study are healthy male & females aged between 18 and 40 years of age having normal skin type with visible Acne PIH and uneven skin tone.
These subjects are selected according to the inclusion/ non inclusion criteria listed in paragraph 3.1.
STUDY DURATION : 28 days following the first application of the product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Participant and Outcome Assessor 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
- •Indian male & female subjects 2)Healthy subjects 3)Skin is healthy on the studied anatomic unit 4)Having normal skin type with visible Acne PIH and uneven skin tone.
排除标准
- •For Females:Being pregnant or breastfeeding or having stopped to breastfeed in the past three months.
- •Having refused to give his/her assent by not signing the consent form and Informed consent form
- •Taking part in another study liable to interfere with this study
- •Being known diabetic case
- •Known asthma case
- •Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis)
- •Being known thyroid case
- •Being epileptic.
- •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 or corticosteroid by any route (the only medication permitted is paracetamol)
- •Known case of hypersensitivity.
- •Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
- •Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
结局指标
主要结局
Reduction of hyperpigmentation and uneven skin tone
时间窗: Baseline, Day 7, Day 14 and Day28
次要结局
未报告次要终点
研究者
Dr Niharika Salian
MASCOT-SPINCONTROL India Pvt. Ltd.