Evaluation of the Efficacy and In Use Safety of Skin Care Formulation in Female Subjects with Postinflammatory Hyperpigmentation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- Reduction in pigmentary intensity
研究概览
简要总结
OBJECTIVE
Primary Objective:
To assess the efficacy of skin care formulation, skinlightening face serum in female subjects with visible facial PIH.
Secondary Objective:
To assess the safety and cosmetic appeal of skin careformulation, skin lightening face serum in female subjects with visible facialPIH.
STUDY DESIGN
This is a non-comparative, prospective, interventionalstudy.
STUDY POPULATION
Enrollment: 128 subjects with facial PIH.
Completed: 115.
The subjects selected for this study are femalesubjects of 18-40 years of age having Fitzpatrick skin type III-V and havingvisible facial PIH (at least one spot of 3mm size).
STUDY DURATION
Screening period: 1 day
Treatment period: 84 days (i.e., 12 weeks)
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Indian female subjects 2)Having Fitzpatrick Skin type 3 to 5 3)Having facial PIH with at least one dark spot more than or equal to 3mm in diameter.
- •Willing to sign the informed consent form to participate in the study and to comply to the protocol and study procedures.
排除标准
- •Female who is pregnant or breastfeeding or has stopped breastfeeding in the past three months 2)Participating in another study liable to interfere with this study 3)Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area 4)Being insulin-dependent diabetic or non insulin-dependent diabetic with a recent therapy (less than 6 months) 5)Having progressive asthma 6)Being epileptic 7)Having non stabilized thyroid problems 8_Having cutaneous hypersensitivity 9)Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products or food products or to latex 10)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) for more than 1 year.
- •Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
- •Having changed her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit.
- •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).
- •Having started, changed or stopped a hormonal treatment (hormonal contraception, Hormone Replacement Therapy) in the past 3 months.
结局指标
主要结局
Reduction in pigmentary intensity
时间窗: Baseline, Day 14, Day 28, Day 56 and Day 84
次要结局
- Safety and cosmetic appeal(Baseline, Day 14, Day 28, Day 56 and Day 84)