Lucky Anne W, Piacquadio Daniel J, Ditre Cherie M, Dunlap Frank, Kantor Irwin, Pandya Amit G, Savin Ronald C, Tharp Michael D
Dermatology Research Associates Inc., Cincinnati, OH 45230, USA.
J Am Acad Dermatol. 2004 Apr;50(4):541-53. doi: 10.1016/j.jaad.2003.06.014.
To pical minoxidil solution 2% stimulates new hair growth and helps stop the loss of hair in men with androgenetic alopecia and women with female pattern hair loss. Results can be variable, and historic experience suggests that higher concentrations of topical minoxidil may enhance efficacy.
The purpose of this 48-week, double-blind, placebo-controlled, randomized, multicenter trial was to compare the efficacy and safety of 5% topical minoxidil with 2% topical minoxidil and placebo in the treatment of female pattern hair loss.
A total of 381 women (18-49 years old) with female pattern hair loss applied 5% topical minoxidil solution (n = 153), 2% topical minoxidil solution (n = 154), or placebo (vehicle for 5% solution; n = 74) twice daily. Primary efficacy variables were change in nonvellus hair count at week 48, and patient and investigator assessments of change in hair growth/scalp coverage at week 48.
After 48 weeks of therapy, 5% topical minoxidil was superior to placebo for each of the 3 primary efficacy measures. The 2% topical minoxidil group demonstrated superiority over placebo for hair count and investigator assessment of hair growth/scalp coverage at week 48; differences in patient assessment of hair growth at week 48 were not significantly different from placebo. The 5% topical minoxidil group demonstrated statistical superiority over the 2% topical minoxidil group in the patient assessment of treatment benefit at week 48. Both 5% and 2% topical minoxidil helped improve psychosocial perceptions of hair loss in women with female pattern hair loss. An increased occurrence of pruritus, local irritation, and hypertrichosis was observed with 5% topical minoxidil versus 2% topical minoxidil and placebo.
In this 48-week study of 381 women with female pattern hair loss, 5% topical minoxidil was superior to placebo on each of the 3 primary efficacy end points: promoting hair growth as measured by change in nonvellus hair count and patient/investigator assessments of hair growth and scalp coverage. Application of 2% topical minoxidil was superior to placebo for assessments of nonvellus hair counts and investigator assessment of hair growth/scalp coverage at week 48; differences in patient assessment of hair growth at week 48 were not significantly different from placebo. At week 48, the 5% topical minoxidil group demonstrated statistical superiority over the 2% topical minoxidil group in the patient assessment of treatment benefit. Both concentrations of topical minoxidil were well tolerated by the women in this trial without evidence of systemic adverse effects. With the introduction of numerous herbal remedies for hair loss, of which most have not been tested in randomized, double-blind, placebo-controlled trials, it is important to describe well-controlled trials that demonstrate the efficacy and safety of topical drugs.
2%的外用米诺地尔溶液可刺激雄激素性脱发男性和女性型脱发女性的头发生长，并有助于防止脱发。效果可能因人而异，以往经验表明，更高浓度的外用米诺地尔可能会增强疗效。
这项为期48周的双盲、安慰剂对照、随机、多中心试验的目的是比较5%外用米诺地尔、2%外用米诺地尔和安慰剂治疗女性型脱发的疗效和安全性。
共有381名年龄在18至49岁之间的女性型脱发女性，每天两次外用5%米诺地尔溶液（n = 153）、2%米诺地尔溶液（n = 154）或安慰剂（5%溶液的赋形剂；n = 74）。主要疗效变量为第48周非毳毛数量的变化，以及患者和研究者对第48周头发生长/头皮覆盖变化的评估。
经过48周的治疗，5%外用米诺地尔在3项主要疗效指标上均优于安慰剂。2%外用米诺地尔组在第48周时，在毛发数量以及研究者对头发生长/头皮覆盖的评估方面优于安慰剂；患者对第48周头发生长的评估差异与安慰剂无显著差异。在第48周患者对治疗益处的评估中，5%外用米诺地尔组在统计学上优于2%外用米诺地尔组。5%和2%的外用米诺地尔均有助于改善女性型脱发女性对脱发的心理社会认知。与2%外用米诺地尔和安慰剂相比，5%外用米诺地尔出现瘙痒、局部刺激和多毛症的发生率增加。
在这项对381名女性型脱发女性进行的48周研究中，5%外用米诺地尔在3项主要疗效终点上均优于安慰剂：通过非毳毛数量变化以及患者/研究者对头发生长和头皮覆盖的评估来衡量促进头发生长。在第48周时，2%外用米诺地尔在非毳毛数量评估以及研究者对头发生长/头皮覆盖的评估方面优于安慰剂；患者对第48周头发生长的评估差异与安慰剂无显著差异。在第48周患者对治疗益处的评估中，5%外用米诺地尔组在统计学上优于2%外用米诺地尔组。在该试验中，两种浓度的外用米诺地尔在女性中耐受性良好，无全身不良反应的证据。随着众多脱发草药疗法的出现，其中大多数尚未在随机、双盲、安慰剂对照试验中进行测试，描述证明外用药物疗效和安全性的严格对照试验非常重要。
