A Randomized Placebo Controlled Clinical study to evaluate the safety & Efficacy of Hairsync H plus in Hair Growth and hairfall with Phototrichogram
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1.SGA (Subject Global Assessment) Questionnaire
研究概览
简要总结
A single blind one group study multiple products study. The trial was conducted as per ICH E6 R2 Guidelines
Below Assessment will be done for 84 days on 60 Healthy Human Volunteers
A. Change in Hair growth, calculated as Subject’s assessment below:
-
Noticed first signs of hair growth
-
Noticed baby hairs or new hairs
-
Noticed darkening of scalp
-
Improvement in hair growth
-
Improvement in hair density
6. Noticed reduction in hair fall
B. Phototrichogram analysis
-
Change in Hair Density
-
Change in A-T Ratio
-
Change in Hair Thickness
-
Change in Percentage of Vellus Hair
-
Change in Percentage of Terminal Hair
Assessment Time: T0min, T+2 days, T+28 days ,T+30 days, T+56 days T+58 days, T+82 days and T+84 days
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 20.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Indian / Asian female and male subjects with Stage 2 and 3
- •Male :Female ratio 50:50 3.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)
- •Between 18 and 45 years of age.
- •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.
- •5.Being insulin-dependent diabetic or non insulin-dependent diabetic with a recent therapy (less than 6 months).
- •6.Having a progressive asthma (either under treatment or last fit in the last 2 years) 7.Being epileptic 8.Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months) Having cutaneous hypersensitivity 9.Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products
- •Following a chronic or intermittent medicinal treatment comprising any of the following products : aspirin-based products, anti-inflammatories, anti-histamines, anti coagulants, corticotherapy, taken by general or local routes(the only medication permitted is paracetamol) 11.Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months 12.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 13.
结局指标
主要结局
1.SGA (Subject Global Assessment) Questionnaire
时间窗: T0min, T+2 days, T+28 days ,T+30 days, T+56 days | T+58 days, T+82 days and T+84 days
2.HD Imaging
时间窗: T0min, T+2 days, T+28 days ,T+30 days, T+56 days | T+58 days, T+82 days and T+84 days
3.Phototrichoscan Assessment
时间窗: T0min, T+2 days, T+28 days ,T+30 days, T+56 days | T+58 days, T+82 days and T+84 days
次要结局
- Not Applicable(Not Applicable)
研究者
Dr Robin Chugh
CCFT Laboratories