Phase III, Parallel Design, Triple-Blind, Randomized, Multicenter Clinical Trial to Evaluate Safety & Efficacy of TH07 Topical Treatment in Male Patients With Androgenic Alopecia.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 420
- 试验地点
- 1
- 主要终点
- Non-vellus hair count
研究概览
简要总结
The goal of this clinical trial is to learn whether a new topical solution, TH07, can help treat androgenic alopecia in men and to learn more about its safety. Participants will be asked to apply either the TH07 solution, a standard hair growth treatment (Minoxidil 5%), or a placebo every day for 24 weeks. At the end of the study, hair growth will be compared in each group to determine which treatment is most effective at increasing hair count.
详细描述
The MATT study is a Phase III clinical trial designed to evaluate the safety and effectiveness of a new topical hair growth treatment called TH07.
TH07 is a combined topical spray solution containing three active ingredients commonly used to treat hair loss: Minoxidil (5%) Finasteride (0.1%) and Latanoprost (0.03%). The study plans to enroll 420 men aged 18 to 49 years old across up to 10 clinical sites.
Participants will be randomly assigned to one of four groups to receive either TH07 (once or twice daily), a standard Minoxidil solution, or a placebo.
The treatment will be applied daily (once or twice) for 24 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males, 18 to 49 years of age on the date of enrollment.
- •Presenting with androgenic alopecia measured as III vertex to V on Hamilton Norwood Scale.
- •Body Mass Index (BMI) in the range of 19 to 35 kg/m
- •Not administered any systemic or topical treatment for AGA during the last 90 days.
- •Willing to comply with the following restrictions for the duration of trial participation:
- •Any systemic or topical treatment of any system of medicine (other than trial treatment) for AGA.
- •Hair dyes, hair texturizers, relaxers etc.
- •Any new vitamins or nutritional supplements that are currently not being administered.
- •Tattooing in the trial target area.
- •Blood donations.
- •OTC hair restorers.
- •Do not expose your pregnant partner to your hands/skin where the drug might be present.
- •Participation in any other drug or device trials during the course of this trial.
- •Note: However, the following shall be permissible:
- •Non-medicated & anti-dandruff shampoos, scalp/hair applications including styling gels, sprays, mousse (styling gels, sprays, mousse etc. not to be used on the days of trial visits to the clinic.
- •Current regimen (if any) of vitamins and nutritional supplements.
- •Willing and able to provide written informed consent for participation in the trial and to comply with all trial requirements.
- •Availability of and usage familiarity with a personal mobile phone (Android or iOS) with internet connectivity and a personal email address.
排除标准
- •History of scalp treatment including though not limited to any of the following:
- •Hair transplant or extension surgery.
- •Hair weaving.
- •Laser or light therapy on the scalp in the last 6 months.
- •Micro-needling or intradermal therapy (mesotherapy) on the scalp including PRP in the last 6 months.
- •5-Any other surgical treatment for hair loss
- •Any of the following hair styles:
- •1.Shaved scalp. 2-Use of occlusive wig, hair extensions, non- breathable wigs.
- •Known or presumed hypersensitivity to any trial treatment medication; history of anaphylaxis to drugs or allergic reactions in general, which in the opinion of investigator may affect the outcome of trial.
- •Any other significant abnormalities indicating of severe, acute or chronic medical condition(s) that may lead to hair loss or otherwise interfere with the interpretation of trial results.
- •History or likelihood of use of any of the specified medicines.
- •History or clinical diagnosis of any of the specified medical conditions.
- •Participation in any investigational or marketed drug or device trial in the last 90 days prior to screening for this trial.
- •Any other condition that in the opinion of the investigator makes the patient unsuitable for inclusion in the trial.
研究组 & 干预措施
Arm A
All participants in Arm A will apply TH07 topical solution twice a day for 24 weeks
干预措施: TH07 (Drug)
Arm B
All participants in Arm B will apply TH07 topical solution once a day and Placebo topical solution once a day for 24 weeks
干预措施: TH07 (Drug)
Arm C
All participants in Arm C will apply Minoxidil 5% topical solution twice a day for 24 weeks
干预措施: Minoxidil 5% Topical Solution (Drug)
Arm D
All participants in Arm D will apply Placebo topical solution twice a day for 24 weeks
干预措施: Placebo (Other)
结局指标
主要结局
Non-vellus hair count
时间窗: Baseline and week 24
Number of hair in the matched target area measured by phototrichogram
次要结局
- Subject-reported improvement(week 24)
- Non-vellus hair count(Baseline and week 24)
- Hair diameter and cumulative hair thickness(Baseline and week 24)
- Incidence of treatment related adverse events.(through study completion, average 28 weeks)