CTRI/2025/07/090415
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 Female Participants with Mild to Moderate Hair loss.
概览
- 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
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 + Women’s Hair growth Supplement) in adult female participants with mild to Moderate Hair loss.
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
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Female
入选标准
- •Adult healthy non-pregnant / non-lactating female participants between the ages of 18 to 60 years (both inclusive) at the time of consent.
- •Participants with Stage I.
- •II of hair loss based on Ludwig scale.
- •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.
- •Participants of childbearing potential must have a negative urine pregnancy test performed at screening visit.
排除标准
- •Participants with clinical diagnosis of hair loss disorder such as alopecia areata, telogen effluvium or scarring forms of alopecia.
- •Participants with history of surgical correction of hair loss on the scalp.
- •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 current hair loss or skin disease (e.g., psoriasis, atopic dermatitis, skin cancer, sun damage, seborrheic dermatitis), infections, cuts, and/or abrasions on the scalp or condition (e.g., sunburn, tattoo) on the treatment area, that in the opinion of the investigator, might put the participant at risk or interfere with the study conduct or evaluations.
- •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 started using hormones for birth control or hormone replacement therapy within the last 6 months.
- •Participants who have undergone hair regrowth treatments (minoxidil, finasteride, PRP, etc.) within 6 months before screening.
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 and Vellus & terminal hair count.(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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