Stein Gold Linda, Del Rosso James Q, Kircik Leon, Bhatia Neal D, Hooper Deirdre, Nahm Walter, Stuart Iain
Dr. Stein Gold is with the Henry Ford Health System in Detroit, Michigan.
Dr. Del Rosso is the Research Director at JDR Dermatology Research in Las Vegas, Nevada.
J Clin Aesthet Dermatol. 2020 Nov;13(11):44-49. Epub 2020 Nov 1.
Efficacy and safety of FMX103 1.5% for papulopustular rosacea were previously demonstrated in two 12-week, Phase 3 studies. We sought to evaluate the safety and efficacy of FMX103 1.5% foam for up to 52 weeks of treatment. Following the completion of two 12-week, double-blind, vehicle-controlled, Phase 3 studies, subjects were invited to enter a 40-week open-label extension study in which all subjects applied FMX103 1.5% once daily. Efficacy endpoints were the reduction in inflammatory lesions and the rate of IGA treatment success from the double-blind baseline. Safety assessments included adverse events, vital signs, laboratory tests, and facial tolerability signs and symptoms. The favorable safety profile of FMX103 1.5% observed in the double-blind studies was maintained over extended treatment lasting up to one year. There were no serious treatment-related adverse events. Long-term treatment with FMX103 1.5% was associated with a greater than 82-percent reduction in inflammatory lesions from baseline and with over 79 percent of subjects achieving treatment success. At the end of the open-label treatment period, over 82 percent of subjects indicated they were overall "satisfied" or "very satisfied" with FMX103 1.5%. All facial local tolerability symptoms improved through Week 52. Due to the nature of the open-label study, lacking a vehicle-treated control, no statistical comparisons can be made. FMX103 1.5% demonstrated a favorable safety and tolerability profile for up to 52 weeks. Long-term efficacy was demonstrated by progressive reductions in inflammatory lesions and increasing IGA treatment success, suggesting that FMX103 1.5% may be a suitable option for the treatment for papulopustular rosacea.
FMX103 1.5%治疗丘疹脓疱型玫瑰痤疮的疗效和安全性先前已在两项为期12周的3期研究中得到证实。我们试图评估FMX103 1.5%泡沫长达52周治疗的安全性和疗效。在两项为期12周的双盲、赋形剂对照3期研究完成后，受试者被邀请进入一项为期40周的开放标签扩展研究，所有受试者每天使用一次FMX103 1.5%。疗效终点是炎症性皮损的减少以及与双盲基线相比IGA治疗成功的比例。安全性评估包括不良事件、生命体征、实验室检查以及面部耐受性体征和症状。在长达一年的延长治疗中，双盲研究中观察到的FMX103 1.5%良好安全性特征得以维持。没有严重的治疗相关不良事件。FMX103 1.5%的长期治疗与炎症性皮损较基线减少超过82%以及超过79%的受试者治疗成功相关。在开放标签治疗期结束时，超过82%的受试者表示他们对FMX103 1.5%总体“满意”或“非常满意”。所有面部局部耐受性症状在第52周时均有所改善。由于开放标签研究的性质，缺乏赋形剂治疗对照，无法进行统计比较。FMX103 1.5%在长达52周的时间里表现出良好的安全性和耐受性特征。炎症性皮损的逐渐减少和IGA治疗成功率的增加证明了其长期疗效，这表明FMX103 1.5%可能是治疗丘疹脓疱型玫瑰痤疮的合适选择。
