Dataset from A Phase 3 Multi-Center Parallel Design Clinical Trial to Compare the Efficacy and Safety of 5 % Minoxidil Foam vs. 2 % Minoxidil Solution in Females for the Treatment of Female Pattern Hair Loss - Androgenetic Alopecia (MINALO3004, NCT01145625)

This is a year-long clinical trial to evaluate the effectiveness and safety in women with Female Pattern Hair Loss (FPHL), comparing a new 5% minoxidil topical foam (MTF) formulation applied once a day versus the 2% minoxidil topical solution (MTS) applied twice a day. This clinical trial uses an objective measurement called Target Area Hair Count (TAHC) to evaluate if there is a change in the number of hairs in the area being examined after using the product for 24 weeks (and also after using the product for 12 Weeks and for 52 weeks). This trial will determine if the benefit of using either study product outweighs the risks.

本研究为一项为期一年的临床试验，旨在评估每日一次使用新型5%米诺地尔外用泡沫剂（5% minoxidil topical foam, MTF）与每日两次使用2%米诺地尔外用溶液（2% minoxidil topical solution, MTS）治疗女性型脱发（Female Pattern Hair Loss, FPHL）患者的有效性与安全性。本临床试验采用目标区域毛发计数（Target Area Hair Count, TAHC）这一客观检测手段，评估受试者使用受试产品12周、24周及52周后，受试区域的毛发数量变化情况。本试验将明确两种研究产品的获益是否超过其潜在风险。