1.0%羟甲唑啉乳膏治疗酒渣鼻相关持续性面部红斑的疗效和安全性关键试验：第二项REVEAL试验结果

Pivotal Trial of the Efficacy and Safety of Oxymetazoline Cream 1.0% for the Treatment of Persistent Facial Erythema Associated With Rosacea: Findings from the Second REVEAL Trial.

作者信息

Baumann Leslie, Goldberg David J, Stein Gold Linda, Tanghetti Emil A, Lain Edward, Kaufman Joely, Weng Emily, Berk David R, Ahluwalia Gurpreet

出版信息

J Drugs Dermatol. 2018 Mar 1;17(3):290-298.

PMID:29537447

Abstract

Rosacea is a chronic dermatologic condition with limited treatment options, particularly for persistent erythema. This pivotal phase 3 study evaluated oxymetazoline, an a1A-adrenoceptor agonist, for the treatment of moderate to severe persistent erythema of rosacea. Eligible patients were randomly assigned 1:1 to receive oxymetazoline cream 1.0% or vehicle applied topically to the face once daily for 29 days. The primary efficacy outcome was ≥2-grade improvement from baseline on both Clinician Erythema Assessment (CEA) and Subject Self-Assessment for rosacea facial redness (SSA) (composite success) at 3, 6, 9, and 12 hours postdose on day 29. Digital image analysis of rosacea facial erythema was evaluated as a secondary efficacy outcome measure. Safety assessments included treatment-emergent adverse events (TEAEs) and dermal tolerability. Patients were followed for 28 days posttreatment to assess worsening of erythema (1-grade increase in severity from baseline on composite CEA/SSA in patients with moderate erythema at baseline; rebound effect). The study included 445 patients (mean age: 50.3 years; 78.7% female); most had moderate erythema at baseline (84.0% on CEA; 91.5% on SSA). The proportion of patients achieving the primary efficacy outcome was significantly greater with oxymetazoline versus vehicle (P=0.001). Similar results favoring oxymetazoline over vehicle were observed for the individual CEA and SSA scores (P less than 0.001 and P=0.011, respectively). Median reduction in rosacea facial erythema on day 29 as assessed by digital image analysis also favored oxymetazoline over vehicle (P less than 0.001). Safety results were similar between oxymetazoline and vehicle; discontinuations due to TEAEs were low (2.7% vs 0.5%). Following cessation of treatment, 2 (1.2%) patients in the oxymetazoline group and no patient in the vehicle group had rebound effect compared with their day 1 baseline score. Topical oxymetazoline applied to the face once daily for 29 days was effective, safe, and well tolerated in the treatment of moderate to severe persistent facial erythema of rosacea.

J Drugs Dermatol. 2018;17(3):290-298.

摘要

酒渣鼻是一种慢性皮肤病，治疗选择有限，尤其是针对持续性红斑。这项关键的3期研究评估了α1A -肾上腺素能受体激动剂奥昔肾上腺素治疗中度至重度酒渣鼻持续性红斑的效果。符合条件的患者按1:1随机分配，分别接受1.0%奥昔肾上腺素乳膏或赋形剂，每天一次面部局部涂抹，持续29天。主要疗效指标是在第29天给药后3、6、9和12小时，临床医生红斑评估（CEA）和酒渣鼻面部发红患者自我评估（SSA）（综合成功）较基线改善≥2级。酒渣鼻面部红斑的数字图像分析作为次要疗效指标进行评估。安全性评估包括治疗中出现的不良事件（TEAE）和皮肤耐受性。治疗后对患者随访28天，以评估红斑恶化情况（基线时中度红斑患者在综合CEA/SSA上严重程度较基线增加1级；反弹效应）。该研究纳入了445例患者（平均年龄：50.3岁；78.7%为女性）；大多数患者基线时为中度红斑（CEA为84.0%；SSA为91.5%）。与赋形剂相比，奥昔肾上腺素组达到主要疗效指标的患者比例显著更高（P = 0.001）。在个体CEA和SSA评分方面也观察到有利于奥昔肾上腺素而非赋形剂的类似结果（分别为P＜0.001和P = 0.011）。通过数字图像分析评估，第29天酒渣鼻面部红斑的中位数减少也有利于奥昔肾上腺素而非赋形剂（P＜0.001）。奥昔肾上腺素和赋形剂的安全性结果相似；因TEAE停药的比例较低（2.7%对0.5%）。治疗停止后，与第1天基线评分相比，奥昔肾上腺素组有2例（1.2%）患者出现反弹效应，赋形剂组无患者出现反弹效应。每天一次面部局部涂抹奥昔肾上腺素持续29天，在治疗中度至重度酒渣鼻持续性面部红斑方面有效、安全且耐受性良好。

《皮肤药物学杂志》。2018年；17(3):290 - 298。