A prospective open labeled clinical trial to evaluate the efficacy and safety of “HAIRAL 7†in hair regrowth and in the treatment of dandruff and hair loss in female and male patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Primary Efficacy Endpoints:
研究概览
简要总结
This study is a prospective open labeled clinical trial which will evaluate the efficacy and safety of “HAIRAL 7†a natural product in hair regrowth and in thetreatment of dandruff and hair loss in female and male patients. Subjects to enter the study should have hairloss and/ or dandruff. All Subjects will be treated with HAIRAL 7 for 4 months.The study drug will be applied to the hair roots daily preferably in the nightfor 4 months.The treatment duration of study will be 4 Monthsfor each subject. this study is sponsored by ABS labs which is present at Hyderabad. The study will recruit 60 subjects within 4 months.
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
- All
入选标准
- •ïƒ˜Males and females of age group 18-40 years Subjects who are suffering from mild to moderate hair loss and/or Subjects suffering from mild to moderate dandruff.
- •ïƒ˜Subjects who are willing to give written informed consent.
排除标准
- •ïƒ˜Any dermatological condition of the scalp other than hair loss and /or dandruff.
- •ïƒ˜Prior use of scalp hair growth treatment (e.g., finasteride, minoxidil) within 6 months Any prior hair growth procedures (e.g., hair transplant or laser) History of alcohol or drug addiction History of skin allergy Regular use of medication which might interfere with the results of the study Subject had used phytotherapy (e.g., saw palmetto) within eight weeks prior to baseline.
- •ïƒ˜Any active skin infection in the scalp area or scarring in the target area.
- •ïƒ˜Photosensitivity to laser light.
- •ïƒ˜Subjects with psoriasis/seborrheic dermatitis Medications with anti-androgenic properties (e.g., cyproterone acetate, spironolactone, ketoconazole, flutamide, bicalutamide), topical estrogen, tamoxifen, anabolic steroids, oral glucocorticoids (or other medications at the discretion of the Investigator.(these are the Medications for hair loss) History of thyroid or other medical condition including polycystic ovary syndrome that might influence hair growth and loss, at the discretion of the Investigator.
- •ïƒ˜Subject had ever received radiation therapy to the scalp, or had chemotherapy within the past year.
结局指标
主要结局
Primary Efficacy Endpoints:
时间窗: 4 months
Investigator assessments
时间窗: 4 months
Reduction in dandruff score for applicable subjects
时间窗: 4 months
Secondary End points:
时间窗: 4 months
Change in global photographic assessment for hair growth
时间窗: 4 months
Change in the investigator assessment score for Hair count each visit from enrollment onwards after treating with IP
时间窗: 4 months
- Subjective Assessment by patient using diary card evaluation
时间窗: 4 months
- Assessment of adverse event
时间窗: 4 months
次要结局
- Subjective Assessment by patient using diary card evaluation(- Assessment of adverse event)