Department of Dermatology and Allergy, Charité-Universitätsmedizin Berlin, Berlin, Germany.
J Am Acad Dermatol. 2011 Dec;65(6):1126-1134.e2. doi: 10.1016/j.jaad.2010.09.724. Epub 2011 Jun 23.
Although twice-daily application of propylene glycol-containing 2% minoxidil topical solution (MTS) stimulates new hair growth, higher concentrations of minoxidil in a once-daily, propylene glycol-free formulation may improve efficacy and reduce unpleasant side effects.
We sought to compare the efficacy, safety, and acceptability and to show noninferiority of once-daily 5% minoxidil topical foam (MTF) with twice-daily 2% MTS in women with androgenetic alopecia.
A total of 113 women with androgenetic alopecia were randomized to 24 weeks of treatment with 5% MTF or 2% MTS. The primary efficacy parameter was change from baseline in nonvellus target area hair count at week 24. Secondary end points included change in nonvellus target area hair width, overall efficacy by global photographic review as assessed by treatment-blinded evaluators and the subject herself, adverse events, and participants' assessment of product aesthetics.
After 24 weeks, women randomized to 5% MTF once daily showed noninferior target area hair count and target area hair width and experienced greater, but nonsignificant, improvements in target area hair count, target area hair width, and overall efficacy by global photographic review than those randomized to 2% MTS used twice daily. 5% MTF was significantly superior to 2% MTS in participants' agreement with "the treatment does not interfere with styling my hair" (P = .002). Women randomized to 5% MTF experienced significantly lower rates of local intolerance (P = .046) especially in pruritus and dandruff compared with 2% MTS.
Because of differences in the formulations tested, study participants were not blinded to treatment.
Once-daily 5% MTF is noninferior and as effective for stimulating hair growth as twice-daily 2% MTS in women with androgenetic alopecia and is associated with several aesthetic and practical advantages.
虽然含有丙二醇的 2%米诺地尔溶液（MTS）每日两次应用可刺激新发生长，但丙二醇-free 配方中更高浓度的米诺地尔每日一次应用可能会提高疗效并减少不良副作用。
我们旨在比较每日一次 5%米诺地尔泡沫剂（MTF）与每日两次 2%MTS 在女性雄激素性脱发中的疗效、安全性和可接受性，并显示其非劣效性。
共 113 例女性雄激素性脱发患者被随机分为 24 周的 5%MTF 或 2%MTS 治疗组。主要疗效参数是治疗 24 周后非毳毛目标区域毛发计数的变化。次要终点包括非毳毛目标区域毛发宽度的变化、治疗盲法评估者和患者自身评估的整体疗效的全球摄影评估、不良事件以及患者对产品美观性的评估。
24 周后，每日一次使用 5%MTF 的患者的目标区域毛发计数和目标区域毛发宽度均显示非劣效性，且在目标区域毛发计数、目标区域毛发宽度和整体疗效的全球摄影评估方面的改善程度更大，但无统计学意义，而每日两次使用 2%MTS 的患者则较差。与 2%MTS 相比，5%MTF 明显更受患者的认同，即“治疗不影响我的头发造型”（P =.002）。与 2%MTS 相比，使用 5%MTF 的患者的局部不耐受发生率显著较低（P =.046），特别是瘙痒和头皮屑。
由于测试的配方不同，研究参与者对治疗方案无法进行盲法评估。
每日一次的 5%MTF 与每日两次的 2%MTS 相比，在女性雄激素性脱发患者中同样可有效刺激毛发生长，且具有一些美学和实用优势。
