一项评估局部用米诺环素泡沫剂 FMX103 治疗面部丘疹脓疱性酒渣鼻的安全性、耐受性和疗效的 II 期、随机、双盲临床研究。

A Phase II, Randomized, Double-Blind Clinical Study Evaluating the Safety, Tolerability, and Efficacy of a Topical Minocycline Foam, FMX103, for the Treatment of Facial Papulopustular Rosacea.

机构信息

Department of Dermatology, Venereology and Allergology, University Medical Center Schleswig-Holstein, Campus Kiel, Kiel, Germany.

Foamix Pharmaceuticals, Ltd, 2 Holzman Street, Weizmann-Science Park, 7670402, Rehovot, Israel.

出版信息

Am J Clin Dermatol. 2018 Jun;19(3):427-436. doi: 10.1007/s40257-017-0339-0.

DOI:10.1007/s40257-017-0339-0

PMID:29396702

Abstract

OBJECTIVE

Our objective was to demonstrate the safety, tolerability, and efficacy of a minocycline foam, FMX103, in the treatment of moderate-to-severe facial papulopustular rosacea.

METHODS

This was a phase II, randomized, double-blind, multicenter study. Healthy subjects aged ≥ 18 years with moderate-to-severe rosacea that had been diagnosed ≥ 6 months previously and with ≥ 12 inflammatory facial lesions were randomized (1:1:1) to receive once-daily 1.5% FMX103, 3% FMX103, or vehicle for 12 weeks. The primary endpoint was the absolute change in inflammatory lesion count at week 12. Other assessments included grade 2 or higher Investigator's Global Assessment (IGA) improvement, IGA "clear" or "almost clear" (IGA 0/1), clinical erythema, and safety/tolerability. Safety and efficacy were evaluated at weeks 2, 4, 8, and 12, with a safety follow-up at week 16.

RESULTS

A total of 232 subjects were randomized; 213 completed the study. At week 12, inflammatory lesion count reduction was significantly greater for the 1.5 and 3% FMX103 doses than for vehicle (21.1 and 19.1 vs. 7.8, respectively; both p < 0.001). Both doses were significantly better than vehicle for achieving grade 2 or higher IGA improvement and assessment of "clear" or "almost clear." Both doses appeared generally safe and well tolerated. In total, 11 (4.7%) subjects reported treatment-related treatment-emergent adverse events (TEAEs); all but one (eye discharge) were dermal related, and all resolved by study end. No treatment-related systemic TEAEs were reported. Four subjects discontinued the study because of TEAEs (3% FMX103, n = 3; vehicle, n = 1).

CONCLUSION

Topical minocycline foam, FMX103, appeared to be an effective, safe, and well tolerated treatment for moderate-to-severe papulopustular rosacea. These results support further investigation in larger clinical trials. CLINICALTRIALS.

GOV IDENTIFIER

NCT02601963.

摘要

目的

本研究旨在评估米诺环素泡沫剂 FMX103 治疗中重度面部丘疹脓疱性酒渣鼻的安全性、耐受性和疗效。

方法

这是一项为期 12 周的 II 期、随机、双盲、多中心研究。纳入年龄≥18 岁、患有中重度酒渣鼻至少 6 个月且面部炎症性皮损≥12 个的健康受试者，按 1:1:1 比例随机分配至每日 1 次接受 1.5% FMX103、3% FMX103 或赋形剂治疗。主要终点为治疗 12 周时炎症性皮损计数的绝对变化。其他评估包括 2 级或更高级别的研究者整体评估（IGA）改善、IGA“清除”或“几乎清除”（IGA 0/1）、临床红斑和安全性/耐受性。治疗后第 2、4、8 和 12 周进行疗效评估，第 16 周进行安全性随访。

结果

共 232 名受试者随机分组，213 名完成研究。治疗 12 周时，1.5% 和 3% FMX103 组的炎症性皮损计数减少均显著大于赋形剂组（分别为 21.1 和 19.1 对 7.8；均 p<0.001）。与赋形剂组相比，这两个剂量均能显著更好地实现 2 级或更高级别的 IGA 改善和“清除”或“几乎清除”评估。两个剂量均显示出良好的安全性和耐受性。共有 11 名（4.7%）受试者报告与治疗相关的治疗中出现的不良事件（TEAE）；除 1 例（眼分泌物）外，所有事件均与皮肤相关，且在研究结束时均已解决。未报告与治疗相关的全身 TEAE。4 名受试者因 TEAE 退出研究（3% FMX103，n=3；赋形剂，n=1）。