Randomized, Placebo-Controlled, Multicenter Clinical Study on the Efficacy and Safety of Lidocaine Patches in Chinese Patients with Postherpetic Neuralgia

Aiping Wang; Hang Li; Zhihong Xie; Lingfeng Li; Xian Jiang; Qing Guo; Fengming Hu; Jianzhong Zhang; Yong Cui; Yangfeng Ding; Hong Fang; Xiuping Han; Shuping Guo; Junlong Wang; Na Ni

doi:10.1007/s13555-023-00938-8

Randomized, Placebo-Controlled, Multicenter Clinical Study on the Efficacy and Safety of Lidocaine Patches in Chinese Patients with Postherpetic Neuralgia

Dermatol Ther (Heidelb). 2023 Jul;13(7):1477-1487. doi: 10.1007/s13555-023-00938-8. Epub 2023 Jun 2.

Authors

Aiping Wang¹, Hang Li², Zhihong Xie³, Lingfeng Li⁴, Xian Jiang⁵, Qing Guo⁶, Fengming Hu⁷, Jianzhong Zhang⁸, Yong Cui⁹, Yangfeng Ding¹⁰, Hong Fang¹¹, Xiuping Han¹², Shuping Guo¹³, Junlong Wang¹⁴, Na Ni¹⁴

Affiliations

¹ Dermatology and Venereology Department, Peking University First Hospital, Beijing, China.
² Dermatology and Venereology Department, Peking University First Hospital, Beijing, China. drlihang@126.com.
³ Dermatology Department, Beijing Hospital, Beijing, China.
⁴ Dermatology and Venereology Department, Beijing Friendship Hospital, Capital Medical University, Beijing, China.
⁵ Dermatology and Venereology Department, West China Hospital, Sichuan University, Chengdu, China.
⁶ Dermatology Department, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China.
⁷ Department of Integrated Chinese and Western Medicine, Dermatology Hospital of Jiangxi Province, Nanchang, China.
⁸ Dermatology Department, Peking University People's Hospital, Beijing, China.
⁹ Dermatology Department, China-Japan Friendship Hospital, Beijing, China.
¹⁰ Dermatology Department, Shanghai Skin Disease Hospital, Shanghai, China.
¹¹ Dermatology Department, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.
¹² Dermatology Department, Shengjing Hospital of China Medical University, Shenyang, China.
¹³ Dermatology Department, First Hospital of Shanxi Medical University, Taiyuan, China.
¹⁴ Clinical Research Center, China State Institute of Pharmaceutical Industry, Shanghai, China.

Abstract

Introduction: To evaluate the efficacy and safety of lidocaine patches in Chinese patients with postherpetic neuralgia (PHN).

Methods: Patients were randomized to receive lidocaine patches or placebo every day for 4 weeks. Efficacy endpoints included the decrease of analogue scale score (VAS) value at week 4, 2 and 1 and the percentage of patients that achieved a 30% decrease of VAS value. Safety analyses were conducted as well.

Results: Two hundred forty Chinese patients were randomized. At week 1, lidocaine patch-treated patients had a higher clinical response versus placebo, and at week 4, the mean (SD) decreases of VAS value compared to the baseline were 14.01 (14.35) in the treatment group and 9.36 (12.03) in the placebo group (p = 0.0088). Overall, the safety profile in the treatment group was consistent with that observed in the placebo group [adverse event (AE) incidence rate: 33.33% versus 37.29%, p = 0.5857].

Conclusions: Lidocaine patches resulted in improved clinical response versus placebo in the treatment of PHN patients and were well tolerated.

Keywords: Clinical study; Efficacy; Lidocaine patch; Postherpetic neuralgia; Safety.