An Investigator Initiated Observational study to assess the Safety & Clinical impact of Curcumin longa based Hair Serum in Indian Patients with AGA & FPHL (SCALP Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 9
- 主要终点
- Change in hair count shedding after shampooing from baseline at 10 weeks.
研究概览
简要总结
This is a Multicenter, Case-cohort, Observational study planned to assess Safety & Clinical impact of Curcumin longa based Hair Serum in Indian Patients with hair loss.
Cuticapil serum is a combination of biotinyl GHK with apigenin a flavonoid from citrus and oleanolic acid from olive tree leaves. Also liposome based Caffeine and Cressantine works on unique mechanism to improve hair growth. It is also enriched with Biotin Plus.
The rationale of this study is to assess real world clinical safety and efficacy of Cuticapil Stem hair serum in patterned hair loss in men & women in India.
As the study will be conducted in the real life setting, study medication will be prescribed by the investigator and the patients will purchase the drug from the pharmacy.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female patients of 18 or above with diagnosis of hair loss Hair shedding > 6 month Clinical diagnosis of male AGA Grade III, Grade IV, Grade V and clinical diagnosis of FPHL Grade II and Grade III naïve cases or treated with 5% Minoxidil.
- •Patients with no known allergy.
- •Patients who agree to refrain from using hair dye, oil treatment or spa treatment, perming or straightening during the treatment/observation period Patients who agree to use Non ketoconazole based shampoo.
排除标准
- •Cosmetic hair treatments 1 month prior to enrolment Patients with Hemoglobin level below 10.5 Patients with thyroid disorders or other systemic disorders including T2DM, Hypertension, HIV, Hepatitis, Anemia, Heart disorders, Cancer & undergone chemotherapy, Depression, any psychiatric disorders and those taking drugs which could cause alopecia Pregnant and lactating females Patients with scalp disease Heavy Smokers & heavy drinkers Patients on crash diets.
结局指标
主要结局
Change in hair count shedding after shampooing from baseline at 10 weeks.
时间窗: at 10 week
Change in hair count with Pull test from baseline at 10 weeks.
时间窗: at 10 week
Global photography assessment at 10 week as centrally adjudicated scale score
时间窗: at 10 week
for hair count.
时间窗: at 10 week
次要结局
- Safety assessment of the hair serum(AGA, FPHL, Patient Global Assessment)