BACKGROUND Randomized controlled studies of combination therapies in rosacea are limited. OBJECTIVE Evaluate the efficacy and safety of combining ivermectin 1% cream (IVM) and doxycycline 40-mg modified-release capsules (ie, 30-mg immediate-release and 10-mg delayed-release beads) (DMR) versus IVM and placebo for treatment of severe rosacea. METHODS This 12-week, multicenter, randomized, investigator-blinded, parallel-group comparative study randomized adult subjects with severe rosacea (Investigator's Global Assessment [IGA] score, 4) to receive either IVM and DMR (combination arm) or IVM and placebo (monotherapy). RESULTS A total of 273 subjects participated. IVM and DMR displayed superior efficacy in reduction of inflammatory lesions (-80.3% vs -73.6% for monotherapy [P = .032]) and IGA score (P = .032). Combination therapy had a faster onset of action as of week 4; it significantly increased the number of subjects achieving an IGA score of 0 (11.9% vs 5.1% [P = .043]) and 100% lesion reduction (17.8% vs 7.2% [P = .006]) at week 12. Both treatments reduced the Clinician's Erythema Assessment score, stinging/burning, flushing episodes, Dermatology Life Quality Index score, and ocular signs/symptoms and were well tolerated. LIMITATIONS The duration of the study prevented evaluation of potential recurrences or further improvements. CONCLUSION Combining IVM and DMR can produce faster responses, improve response rates, and increase patient satisfaction in cases of severe rosacea.

中文翻译：

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一项随机3b / 4期研究评估了局部使用伊维菌素1％乳膏和强力霉素40 mg缓释胶囊与局部使用伊维菌素1％乳膏和安慰剂同时治疗严重酒渣鼻的疗效。

背景技术酒渣鼻中联合疗法的随机对照研究是有限的。目的评估伊维菌素1％乳膏（IVM）和强力霉素40 mg缓释胶囊（即30 mg速释和10 mg缓释微珠）（DMR）与IVM和安慰剂联合使用的有效性和安全性治疗严重的酒渣鼻。方法这项为期12周，多中心，随机，研究者双盲，平行分组的比较研究对患有严重酒渣鼻的成人受试者（研究者的整体评估[IGA]评分，4]进行了随机分组，以接受IVM和DMR（联合治疗）或IVM和安慰剂（单一疗法）。结果共有273名受试者参加。IVM和DMR在减少炎​​性病变（单药治疗[-80.3％vs -73.6％] [P = .032]）和IGA评分[P = .032]方面显示出优异的疗效。从第4周开始，联合疗法起效更快；在第12周时，IGA得分达到0（11.9％vs 5.1％[P = .043]）和减少100％病变（17.8％vs 7.2％[P = .006]）的受试者人数显着增加。两种治疗降低了临床医师的红斑评估评分，刺痛/灼痛，潮红发作，皮肤病生活质量指数评分和眼部症状/症状，并且耐受性良好。局限性研究持续时间未能评估潜在的复发或进一步的改善。结论在严重酒渣鼻病例中，将IVM和DMR结合使用可产生更快的反应，提高反应率并提高患者满意度。在第12周时分别为8％和7.2％[P = .006]。两种治疗均降低了临床医师的红斑评估评分，刺痛/烧伤，潮红发作，皮肤病生活质量指数评分和眼部症状/症状，并且耐受性良好。局限性研究持续时间未能评估潜在的复发或进一步的改善。结论在严重酒渣鼻病例中，将IVM和DMR结合使用可产生更快的反应，提高反应率并提高患者满意度。在第12周时分别为8％和7.2％[P = .006]）。两种治疗均降低了临床医师的红斑评估评分，刺痛/烧伤，潮红发作，皮肤病生活质量指数评分和眼部症状/症状，并且耐受性良好。局限性研究持续时间未能评估潜在的复发或进一步的改善。结论在严重酒渣鼻病例中，将IVM和DMR结合使用可产生更快的反应，提高反应率并提高患者满意度。