Background

Limited treatments are available for persistent erythema of rosacea.

Objective

To examine the long-term safety and efficacy of oxymetazoline cream 1.0% in patients with rosacea with moderate-to-severe persistent erythema.

Methods

Patients applied oxymetazoline once daily for 52 weeks. Safety assessments included treatment-emergent adverse events (TEAEs), skin blanching, inflammatory lesion counts, telangiectasia, disease severity, and rebound effect. Efficacy was assessed by the Clinician Erythema Assessment and Subject Self-Assessment composite score at 3 and 6 hours after the dose on day 1 and at weeks 4, 26, and 52.

Results

Among 440 patients, 8.2% reported treatment-related TEAEs; the most common were application-site dermatitis, paresthesia, pain, and pruritus. The rate of discontinuation due to adverse events (mostly application-site TEAEs) was 3.2%. No clinically meaningful changes were observed in skin blanching, inflammatory lesions, or telangiectasia. At week 52, 36.7%, and 43.4% of patients achieved a 2-grade or greater composite improvement from baseline in both Clinician Erythema Assessment and Subject Self-Assessment 3 and 6 hours after a dose, respectively. Less than 1% of patients experienced a rebound effect following treatment cessation.

Limitations

A vehicle-control group was not included.

Conclusion

This long-term study demonstrated sustained safety, tolerability, and efficacy of oxymetazoline for moderate-to-severe persistent erythema of rosacea.

中文翻译：

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1.0％羟甲唑啉乳膏治疗与酒渣鼻相关的持续性面部红斑的功效和安全性：52周开放标签的REVEAL试验发现

背景

酒渣鼻持续性红斑的治疗方法有限。

客观的

检验1.0％羟甲唑啉乳膏对酒渣鼻伴中度至重度持续性红斑的长期安全性和有效性。

方法

患者每天应用一次氧甲唑啉，持续52周。安全性评估包括治疗紧急不良事件（TEAE），皮肤变白，炎性病变计数，毛细血管扩张，疾病严重程度和反弹作用。通过临床红斑评估和受试者自我评估综合评分在第1天给药后第3和6小时以及第4、26和52周进行疗效评估。

结果

在440例患者中，有8.2％的患者报告了与治疗有关的TEAE；最常见的是应用部位的皮炎，感觉异常，疼痛和瘙痒。因不良事件（主要是应用现场TEAE）引起的停药率是3.2％。在皮肤变白，发炎性病变或毛细血管扩张方面未观察到具有临床意义的变化。在第52周时，分别在给药后3和6小时，临床红斑评估和受试者自我评估均较基线获得了2级或更高的综合改善，分别占36.7％和43.4％的患者。停止治疗后不到1％的患者出现反弹作用。

局限性

不包括车辆对照组。

结论

这项长期研究证明了羟甲唑啉对酒渣鼻中至重度持续性红斑的持续安全性，耐受性和疗效。