Graduate School of Public Health, Shizuoka Graduate University of Public Health, Shizuoka, Japan.
Department of Dermatology, Tohoku University Graduate School of Medicine, Sendai, Japan.
J Dermatol. 2022 Mar;49(3):330-340. doi: 10.1111/1346-8138.16254. Epub 2021 Dec 1.
Topical metronidazole is not currently approved in Japan as a treatment for the indication of rosacea, although 0.75% metronidazole gel was authorized in 2014 for the management of cancerous skin ulcers. We conducted a randomized, double-blind, vehicle-controlled study to evaluate the efficacy and safety of 0.75% metronidazole gel in Japanese patients with inflammatory lesions (papules/pustules) and erythema associated with moderate to severe rosacea. Overall, 130 patients were randomly assigned to receive 0.75% metronidazole gel (n = 65) or vehicle (n = 65), and 120 patients completed 12 weeks of treatment. The primary efficacy outcome was the proportion of patients who achieved both of the following at week 12: an improvement of >50% in the number of inflammatory lesions (papules/pustules) and a positive change of at least one degree in erythema severity. This composite outcome was achieved by 72.3% of metronidazole-treated patients versus 36.9% of vehicle-treated patients, with the between-group difference demonstrating significant improvement with 0.75% metronidazole gel (p < 0.0001). All secondary efficacy endpoints (patients achieving a score of ≥3 for percent change in the number of inflammatory lesions at week 12; patients achieving a score of ≥3 for change in erythema severity at week 12; patients achieving an Investigator's Global Assessment score of 0 or 1 at week 12; percent change over time in the number of inflammatory lesions; change over time in erythema severity) also showed improvement in the 0.75% metronidazole gel group. The incidence of adverse events was higher with metronidazole (40.0%) than with vehicle (29.2%). Of these, treatment-related, treatment-emergent adverse events occurred in 9.2% and 6.2% in the metronidazole and the vehicle group, respectively, but there were no new safety concerns. Overall, the results of this study have confirmed the efficacy and safety of 0.75% metronidazole gel in Japanese patients with rosacea.
甲硝唑凝胶（Topical metronidazole）目前尚未在日本获得批准用于治疗酒渣鼻，但在 2014 年，0.75%的甲硝唑凝胶被批准用于治疗癌症皮肤溃疡。我们进行了一项随机、双盲、对照研究，以评估 0.75%甲硝唑凝胶在日本患有中重度酒渣鼻伴炎症性皮损（丘疹/脓疱）和红斑的患者中的疗效和安全性。总体而言，共有 130 名患者被随机分配接受 0.75%甲硝唑凝胶（n=65）或赋形剂（n=65）治疗，并完成了 12 周的治疗。主要疗效终点为治疗 12 周时同时达到以下两项标准的患者比例：炎症性皮损（丘疹/脓疱）数量改善≥50%，红斑严重度改善至少 1 度。接受甲硝唑凝胶治疗的患者中有 72.3%达到了这一复合终点，而接受赋形剂治疗的患者中仅有 36.9%，两组之间的差异具有统计学意义（p<0.0001）。所有次要疗效终点（治疗 12 周时炎症性皮损数量变化评分≥3 的患者比例；治疗 12 周时红斑严重度变化评分≥3 的患者比例；治疗 12 周时研究者总体评估评分 0 或 1 的患者比例；炎症性皮损数量随时间的变化百分比；红斑严重度随时间的变化）也显示了 0.75%甲硝唑凝胶的改善。甲硝唑凝胶组的不良反应发生率（40.0%）高于赋形剂组（29.2%）。其中，甲硝唑凝胶组和赋形剂组分别有 9.2%和 6.2%的患者出现与治疗相关的治疗中出现的不良反应，但无新的安全性问题。总体而言，这项研究的结果证实了 0.75%甲硝唑凝胶在日本酒渣鼻患者中的疗效和安全性。
