National, Multicentre, Randomized, Double-blind, Double-dummy Phase III Clinical Trial to Evaluate the Efficacy and Safety of Finlândia Hair Lotion Association in the Treatment of Androgenetic Alopecia.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- Change from baseline in hair density.
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of Finlândia hair lotion association in the treatment of androgenetic alopecia.
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)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
- •Men aged 18 years or over and less than or equal to 60 years with a diagnosis of Androgenetic Alopecia grades IIIv to IV in the modified Norwood-Hamilton classification, who have been using minoxidil 5% for at least 3 months and willing to maintain the same style, approximate length and hair color throughout the test.
排除标准
- •Known hypersensitivity to the formula components used during the clinical trial;
- •History of alcohol and/or substance abuse within 2 years;
- •Participants with other concomitant dermatological diseases on the scalp, except for mild seborrhoea dermatitis;
- •Participants with a history of surgical treatment for hair loss or shaved scalp;
- •Participants who used shampoo or topical solution containing ketoconazole, tar, selenium, threonine or steroids in the last 2 weeks;
- •Participants who used 5α reductase inhibitors, such as finasteride and dutasteride, in the last 12 months;
- •Participants using testosterone replacement therapy (TRT) or using testosterone-containing gel;
- •Participants who used micro-infusion of medications on the skin (MMP), microneedling or intradermotherapy on the scalp in the last 3 months;
- •Participants who have undergone radiation treatment for the scalp or chemotherapy in the past year;
- •Participants with diseases that can affect hair growth;
- •Participants with a current medical history of cancer and / or cancer treatment in the last 5 years;
研究组 & 干预措施
FINLÂNDIA
The study is double-dummy. The patient must take 1 pill and apply hair lotion as follow:
1 tablet finasteride placebo, oral, once a day.
1 mL Finlândia hair lotion, topical, twice a day.
干预措施: Finlândia Association + finasteride placebo (Drug)
Minoxidil + finasteride
The study is double-dummy. The patient must take 1 pill and apply hair lotion as follow:
1 tablet finasteride, oral, once a day.
1 mL minoxidil hair lotion, topical, twice a day.
干预措施: Minoxidil + finasteride (Drug)
结局指标
主要结局
Change from baseline in hair density.
时间窗: 6 months
Digital phototrichogram evaluation of vertex area regarding the change from baseline in number of hairs after 6 months of treatment compared to baseline.
次要结局
- Incidence and severity of adverse events recorded during the study.(6 months)