CTRI/2024/08/071885招募中不适用
Exploratory, prospective, three-arm, interventional, comparative, randomized, double-blind, placebo-controlled, safety, efficacy and in-use tolerability study of hair growth product(s) in patients with mild to moderate androgenic alopecia. (Grade I to III).
Zywie Ventures Privated Ltd1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2024年8月9日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- 1.To assess the effectiveness of the test products in terms of change in hair thickness, and hair density by using CASLite Nova
研究概览
简要总结
This is an exploratory, prospective, three-arm, interventional, comparative, randomized, double-blind, placebo-controlled, safety, efficacy and in-use tolerability study of hair growth products in the patients mild to moderate androgenic alopecia (Grade I to III).
A total of up to 54 patients (18 patients/arm) preferably equal number of male and female will be enrolled to ensure a total of 45 patients (15 patients/ arm) to complete the study.
There will be total of 8 visits during the study. The duration of the study will be 180 days (6 months) from the enrolment.
visit 1 screeing
visit 2 enrollment baseline evaluation
visit 3 product phase and evaluation
visit 4 tattoo creation and evaluation
visit 5 evaluations
visit 6 evaluations
visit 7 tattoo creation and evaluation
visit 8 evaluation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Age: 25 to 45 years and above (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 (containing Minoxidil), any other hair growth products or hair colour or dye, other than the test products for the entire duration of the study.
- •Willing to use test products throughout the study period.
- •Subject is willing and able to follow and allow study staff to performed study test methods.
- •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.
- •Subject 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.To assess the effectiveness of the test products in terms of change in hair thickness, and hair density by using CASLite Nova
时间窗: 1. Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90, Day 135 and on Day 180 | 2. 04 days before Day 01, Day 01, Day 87, Day 90 and on Day 177, on Day 180
2.To assess the effectiveness of the test products in terms of change in hair growth rate by using CASLite Nova
时间窗: 1. Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45, Day 90, Day 135 and on Day 180 | 2. 04 days before Day 01, Day 01, Day 87, Day 90 and on Day 177, on Day 180
次要结局
- To assess the effectiveness of the test products in terms of change in keratin(measurement from scalp by using CASLite Nova(From Androgenic Alopecia affected targeted area and normal scalp- tattoo area))
- 2. To assess the effectiveness of the test products in terms of change in hair length by using CASLite Nova and calibrated ruler(Baseline before usage of the test products on Day 01 and after usage of the test products on Day 45 , Day 90, Day 135 and on Day 180)
- To assess the effectiveness of the test products in terms of change in A:T ratio(by hair pluck test)
- To assess the effectiveness of the test products in terms of change hair fall(from root test by 60 seconds hair combing test)
- To assess the effectiveness of the test products in terms of change in number(of new hairs by using CASLite Nova)
- To assess the effectiveness of the test products in terms of change in hair(regrowth by using CASLite Nova)
- To assess the effectiveness of the test products in terms of change in hair(strength from root by dermatological assessment)
- To assess the effectiveness of the test products in terms of change in general(appearance of hair i.e. hair volume, hair plasticity, hair density, hair)
- To assess the effectiveness of the test products in terms of change in general(appearance of scalp i.e. Itchiness, redness, roughness, and scaliness)
- To evaluate the effectiveness of the test products in terms of change in(products perception questionnaire)
- To assess the effectiveness of the test products in terms of change in tensile(strength of hairs)
研究者
Dr Nayan Patel
NovoBliss Research Private Limited
研究点 (1)
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