"Comparison of a New 5% Minoxidil Foam and Rogaine((R)) in the Treatment of Androgenetic Alopecia in Chinese Men: A Randomized, Double-Blind, Phase III, Equivalence Trial"

作者全名："Zhou, Cheng; Fan, Weixin; Zou, Jianfeng; Zhang, Jianglin; Fang, Hong; Lv, Zhongfa; Yang, Dingquan; Lai, Wei; Gao, Xinghua; Yang, Qinping; Chen, Aijun; Lou, Jing; Zheng, Lili; Zhang, Jianzhong"

作者地址："[Zhou, Cheng; Zhang, Jianzhong] Peking Univ Peoples Hosp, Dept Dermatol, Beijing, Peoples R China; [Fan, Weixin] Nanjing Med Univ, Affiliated Hosp 1, Dept Dermatol, Nanjing, Peoples R China; [Zou, Jianfeng] Peoples Liberat Army Gen Hosp, Dept Crit Care Med, Med Ctr 6, Beijing, Peoples R China; [Zhang, Jianglin] Cent South Univ, Xiangya Hosp, Dept Dermatol, Changsha, Peoples R China; [Fang, Hong] Zhejiang Univ, Affiliated Hosp 1, Sch Med, Dept Dermatol, Hangzhou, Peoples R China; [Fang, Hong] Zhejiang Univ, Affliated Hosp 1, Sch Med, STD, Hangzhou, Peoples R China; [Lv, Zhongfa] Zhejiang Univ, Affiliated Hosp 2, Sch Med, Dept Dermatol, Hangzhou, Peoples R China; [Lv, Zhongfa] Zhejiang Univ, Affliated Hosp 2, Sch Med, STD, Hangzhou, Peoples R China; [Yang, Dingquan] China Japan Friendship Hosp, Dept Dermatol, Beijing, Peoples R China; [Lai, Wei] Sun Yat Sen Univ, Affiliated Hosp 3, Dept Dermatol, Guangzhou, Peoples R China; [Gao, Xinghua] China Med Univ, Hosp 1, Dept Dermatol, Shenyang, Peoples R China; [Yang, Qinping] Fudan Univ, Huashan Hosp, Dept Dermatol, Shanghai, Peoples R China; Chongqing Med Univ, Affiliated Hosp 1, Dept Dermatol, Chongqing, Peoples R China; [Chen, Aijun] Chongqing Med Univ, Affliated Hosp 1, STD, Chongqing, Peoples R China; Shenyang Sunshine Pharmaceut CO Ltd, Shenyang, Peoples R China"

通信作者："Zhang, JZ (通讯作者)，Peking Univ Peoples Hosp, Dept Dermatol, Beijing, Peoples R China."

来源：DERMATOLOGIC THERAPY

ESI学科分类：CLINICAL MEDICINE

WOS号：WOS:000977055600002

JCR分区：Q1

影响因子：3.7

年份：2023

卷号：2023

期号：　

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结束页：　

文献类型：Article

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摘要："Androgenetic alopecia (AGA) is a common cause of hair loss in adults. We aimed to compare the e5cacy and safety of topical generic 5% new minoxidil foam (NMF) versus 5% minoxidil Rogaine((R)) foam in male patients with AGA. A randomized, doubleblind, controlled, phase III, equivalence trial in 10 centers in China between December 25, 2019, and June 28, 2021, was performed. In total, 417 men patients (>= 18 years) with AGA were randomized to receive 5% NMF (211 patients) or 5% Rogaine((R)) foam (206 patients) 1 g two times daily for 24 weeks.,eprimary outcome was the changes in nonvellus target area hair counts (TAHC) from baseline to week 24. Equivalence was concluded if the 95% conCdence interval (CI) for the treatment diDerence between the 5% NMF and Rogaine((R)) groups was within (-8.00, 8.00). After 24 weeks of treatment, the mean diDerence in the change of nonvellus TAHC between the 5% NMF group and the Rogaine((R)) group was -3.85 +/- 1.62 hair/cm(2) in full-analysis set (FAS) and -3.96 +/- 1.68 hair/cm(2) in per-protocol set (PPS), and the 95% CI of mean diDerence was (-7.03, -0.67) in FAS and (-7.26, -0.66) in PPS. No signiCcant diDerences were found between the two groups in hair diameter, the ratio of terminal hair to vellus hair, the global photographic assessment by investigators, and adverse events (all P > 0.05). 5% NMF is as eDective as Rogaine((R)) in increasing hair density and hair diameter in AGA patients and was found to be safe.,is trial is registered with CTR20191708."

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