CTRI/2025/07/090485尚未招募不适用
An open label, single-arm, clinical study to evaluate the efficacy and safety of a test regime in lactating female with hair fall.
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
- Clinical assessment of hair fall and 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 + Women’s Post-partum Hair growth Supplement) in lactating female with hair fall.
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
- 20.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Healthy lactating female subjects with age between 20 and 40 years (both inclusive at the time of consent).
- •Participants complaining about having at least 50 to 100 hair fall per day.
- •Participants with 50 counts of hair fall from hair combing method (60-sec hair count).
- •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 or scarring forms of alopecia.
- •Participants with hair loss due to Autoimmune disorder/ Chemotherapy/ immunosuppressive drugs.
- •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.
- •Participants who using any products/devices aimed to promote scalp hair growth within the 6 months prior to study initiation.
- •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.
- •Any other condition which could warrant exclusion from the study, as per the investigator’s discretion.
结局指标
主要结局
Clinical assessment of hair fall and 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 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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