CTRI/2025/07/091602尚未招募不适用
An Open Label, Non-Randomized, Single-Arm, Clinical Study to Evaluate the Efficacy and Safety of a Test Regime in Adult Male Participants with Mild to Moderate Alopecia.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Instrumental assessment of Hair thickness and Hair growth rate
研究概览
简要总结
This is an open label, non-randomized, single-arm, clinical study to evaluate the efficacy and safety of a test regime (Topical Serum + Men’s Hair growth Supplement + Men’s DHT Blocker Supplement) in adult male participants with mild to moderate alopecia.
The potential participants will be screened as per the inclusion and exclusion criteria only after obtaining written informed consent from the participants.
All eligible participants will undergo instrumental assessments, dermatological assessments, laboratory assessments (blood tests) and subjective assessment. Safety will be assessed throughout the study by monitoring adverse events and changes in vital signs (Body temperature, Pulse rate and Blood pressure).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 40.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Male
入选标准
- •Adult male participants between the ages of 40 to 60 years (both inclusive) at the time of consent.
- •Participants with Norwood Pattern II to IV of hair loss.
- •Participants who are experiencing hair thinning or excessive shedding for at least 3–6 months.
- •Participants with minimum hair length of 2 inches.
- •Participants having good general health as determined by the Investigator on the basis of medical history and vital signs.
排除标准
- •Participants with clinical diagnosis of hair loss disorder such as alopecia areata, or scarring forms of alopecia or advanced pattern hair loss.
- •Participants with scalp hair loss at the treatment area, due to disease, injury, or medical therapy.
- •Participants with history of any dermatological condition (like psoriasis or infections) of the scalp other than hair loss OR with any active scalp disease which may interfere in the study.
- •Participants with any clinically significant systemic or cutaneous disease, which may interfere with study treatments or procedures.
- •Participants with a history of chronic health conditions (eg, diabetes, hypertension, chronic renal failure, heart and liver disease), endocrine abnormalities including stable thyroid disease, psychiatric illness, bariatric surgery/eating disorders such as bulimia or binge eating, cardiovascular surgery, or history of any other major surgery.
- •Participants with the history of malignancy OR known history of autoimmune thyroid disease, any other thyroid disorder/abnormality or other autoimmune disorders.
- •Participants with known allergy or sensitivity to cosmetic products and/or any ingredients of the test product.
- •Participants who had undergone chemotherapy or radiation within the last 2 years.
- •Participants who have undergone hair regrowth treatments (minoxidil, finasteride, PRP, etc.) within 6 months before screening.
- •Participants using anti-androgenic therapies or using low-level lasers for hair growth within 3 months.
- •Participants who have applied topical treatment for hair loss for at least 4 weeks and any systemic treatment for at least 3 months, prior to their participation in the study.
- •Participants with a history or presence of significant alcoholism or drug abuse and smoking or consumption of tobacco products.
结局指标
主要结局
Instrumental assessment of Hair thickness and Hair growth rate
时间窗: Day 00, Day 45 and Day 90
次要结局
- Clinical assessment of anagen and telogen ratio (A:T ratio), hair fall, hair strength, hair and scalp related parameters(Day 00, Day 45 and Day 90)
- Instrumental assessment of hair density.(Day 00, Day 45 and Day 90)
- Laboratory assessments of hormonal and nutritional blood markers(Day 00 and Day 90)
- Participant Evaluation Questionnaire(Day 45 and Day 90)
研究者
Dr Bhagirath Patel
Cliantha Research
研究点 (1)
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