A Randomized, Double Blind, Parallel-group Study to Evaluate the Efficacy and Safety of a New Pharmaceutical Form Minoxidil 5% for the Treatment of Androgenetic Alopecia in Men for 24 Weeks
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 336
- 试验地点
- 1
- 主要终点
- Absolute change in terminal thread density in the target area determined 180 (±3) days after the start of treatment compared to baseline density.
研究概览
简要总结
A prospective, randomized, double-blind, single-center, placebo-Controlled, parallel-group study to evaluate the efficacy and safety of a new pharmaceutical form Minoxidil 5% in men after 24 weeks of treatment.
⚠️Study will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil).
详细描述
Participants will be randomized at a 2: 1 ratio to receive new pharmaceutical form Minoxidil 5% and placebo, respectively. Through this method, it is possible to obtain more information about the effectiveness of investigational product.
The primary objective of the MINOX study is to demonstrate the superiority of a new topical 5% pharmaceutical form of minoxidil (experimental drug) in treating men with androgenetic alopecia (Hamilton-Norwood scale IIIv, IV or V) compared to placebo when administered for 180 days.
Secondary objectives: 1- To evaluate the efficacy of a new topical 5% minoxidil pharmaceutical form in the treatment of men with androgenetic alopecia, compared to placebo, by means of terminal strand density in the target area, evaluated 30 (±3), 60(±3), 90(±3) and 135(±3) days after the beginning of treatment.
2- To evaluate the efficacy of a new topical 5% pharmaceutical form of minoxidil in the treatment of men with androgenetic alopecia, compared to placebo, by means of the percentage of anagen strands in the target area, evaluated 30(±3), 60(±3), 90(±3), 135(±3) and 180(±3) days after the start of treatment.
3- Evaluate the efficacy of a new topical 5% pharmaceutical form of minoxidil in the treatment of men with androgenetic alopecia, compared to placebo, by means of the average length of hair strands in the target area, evaluated 30(±3), 60(±3), 90(±3), 135(±3) and 180(±3) days after the start of treatment.
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
- Double (Participant, Investigator)
盲法说明
Masking will be adopted in this study, in which the experimental products under evaluation will be provided in a masked way, that is, one group will receive an experimental drug (Minoxidil 5%) and another group will receive a placebo (product without the active ingredient) in identical primary and secondary packaging to avoid potential bias, so neither the researcher nor the research participant will know what is being applied.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 65 years;
- •Male pattern baldness identified according the Norwood Hamilton scale: stage IIIv vertex, stage IV, or stage V;
- •Terminal hair density equal to or less than 220 hairs/cm2 measured with the Trichoscale Al;
- •Subjects who are willing and able to comply with all requirements of the study for the intended period;
- •Subjects who give their consent to the study after thoroughly clarification and who personally signed and dated the informed consent document has been informed of all pertinent aspects of the trial;
排除标准
- •Current or 6 months dated back use of:
- •Minoxidil, finasteride, or any 5 alpha-reductase inhibitor;
- •Medications that can potentiate Hypertrichosis, such as: cyclosporine, phenytoin, psolarenes, oral glucocorticoids (except inhalers), lithium, phenothiazinics
- •Medications with anti-androgenic properties, such as: cyproterone, spironolactone, ketoconazole, flutamide, bicalutamide.
- •Any anabolic steroid ;
- •Current or 8 weeks dated back use of herbal products such as saw palmetto;
- •Isotretinoin for at least 12 months;
- •Current or 2 weeks dated back use of dietary or vitamin supplements;
- •Subjects who had a dignosis of malignant disease in the alopecia area in the period of 05 years;
研究组 & 干预措施
Minoxidil´s Placebo
The recommended dosage is 1 ml of the solution twice a day (morning and evening).
干预措施: Placebo (Drug)
Topical Minoxidil 5%
The recommended dosage is 1 ml of the solution twice a day (morning and evening).
干预措施: Minoxidil Topical Foam (Drug)
结局指标
主要结局
Absolute change in terminal thread density in the target area determined 180 (±3) days after the start of treatment compared to baseline density.
时间窗: 24 weeks
The density of terminal hairs will be evaluated by phototrichogram (FotoFinder leviacam® and Trichoscale Al® Dermatoscope), with the baseline density resulting from the images captured on the VR and VR+2 days visits and the final density resulting from the images captured on the V5 and V5+2 days visits. Terminal wires will be classified as those with diameter greater than or equal to 30 um.
次要结局
未报告次要终点