CTRI/2025/05/086158尚未招募不适用
A Single-Arm, Single-centre, Study Evaluate the Safety and Efficacy of a Hair Growth Serum in Patients with Mild to Moderate Androgenic Alopecia (Grades I–III).
OneSto Labs Private Ltd.1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2025年12月5日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- 1. hair growth (in terms of hair length)
研究概览
简要总结
This is a prospective, single- arm, single- centre, open -label, clinical safety and efficacy study of hair growth serum in the patients with mild to moderate AGA (Grade I-III)
A total of 32 subjects with an age of 18-55 years of age will be enrolled to complete 30 subjects of the study.
subjects will be instructed to visit the facility as per below visit:
Visit 01 (Day 01): Screening, Enrolment, baseline evaluation
Visit 02 (Day 40): Treatment usage period, and Evaluation Visit
Visit 03 (Day 80):Treatment Usage Period and Evaluation Visit
Visit 04 (Day 120): Evaluation and End of Study
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Age: 18-55 years (both inclusive) at the time of consent.
- •Sex: Males and non-pregnant/non-lactating females (preferably equal number of males and females).
- •Females of childbearing potential must have a self-reported negative urine pregnancy.
- •Subject is in good general health as determined by the Investigator on the basis of medical history.
- •Patients having mild to moderate androgenic alopecia (Grade I to III) during clinical study and grade will be evaluated by the dermatologist by using Norwood-Hamilton classification and Ludwig pattern scale for female.
- •Female with 40-50 counts and male with 25 -30 counts of hair fall at screening.
- •Subject is able to remain on stable doses of contraceptive or replacement hormonal therapy, including no therapy, 6 weeks prior to and for the duration of the study.
- •If the subject is of childbearing potential, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device/injection, regular use of birth control pills or patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or foam, partner vasectomy or abstinence).
- •Females will be considered as non-childbearing potential if they are surgically sterile, have been post-menopausal for at least 1 year or have had a tubal ligation.
- •Patients who commit not to use any other medicated/ prescription shampoos/hair care products, any other hair growth products or hair colour or dye, other than the test treatment for the entire duration of the study.
- •Willing to use test treatment throughout the study period.
- •Subject is willing and able to follow the study directions, to participate in the study, returning for all specified visits.
- •Subject must be able to understand and provide written informed consent to participate in the study.
排除标准
- •Subject have history of severe hair fall due to any clinically significant problems like anaemia, thyroid problems.
- •Subject have history of any dermatological condition of the scalp other than hair loss and dandruff.
- •Subject have history of any prior hair growth procedures (e.g. hair transplant or laser).
- •Subject who had taken topical treatment of hair loss for at least 4 weeks.
- •Subject who had taken any systemic treatment for at least 3 months.
- •History of alcohol or drug addiction.
- •Subject having history or resent condition of irritated or visibly inflamed scalp or severe scalp disease.
- •Subject having history or present condition of an allergic response to any cosmetic products, any other condition which could warrant exclusion from the study.
- •Pregnant or breast feeding or planning to become pregnant during the study period.
- •History of chronic illness which may influence the cutaneous state.
- •Subjects have history of mastectomy for cancer involving removal of lymph nodes within the past year, or treatment of any type of cancer within the last 6 months.
结局指标
主要结局
1. hair growth (in terms of hair length)
时间窗: Day 01, Day 40, Day 80 and Day 120
2. hair thickness and hair density
时间窗: Day 01, Day 40, Day 80 and Day 120
To evaluate the effectiveness of the test treatment in terms of change in
时间窗: Day 01, Day 40, Day 80 and Day 120
次要结局
- To evaluate the effectiveness of the test treatment in terms of change in(1. Change in A: T)
研究者
研究点 (1)
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