Linda Stein Gold1,2,3,4,5,6,7, James Q Del Rosso1,2,3,4,5,6,7, Leon Kircik1,2,3,4,5,6,7, Neal D Bhatia1,2,3,4,5,6,7, Deirdre Hooper1,2,3,4,5,6,7, Walter Nahm1,2,3,4,5,6,7, Iain Stuart1,2,3,4,5,6,7. 1. Dr. Stein Gold is with the Henry Ford Health System in Detroit, Michigan. 2. Dr. Del Rosso is the Research Director at JDR Dermatology Research in Las Vegas, Nevada. 3. Dr. Kircik is with the Icahn School of Medicine at Mount Sinai in New York, New York. 4. Dr. Bhatia is with Therapeutics Clinical Research in San Diego, California. 5. Dr. Hooper is with Delricht Research in New Orleans, Louisiana. 6. Dr. Nahm is with the University of California at the San Diego School of Medicine in San Diego, California. 7. Dr. Stuart is with VYNE Therapeutics Inc. in Bridgewater, New Jersey.
Abstract
BACKGROUND:Efficacy and safety of FMX103 1.5% for papulopustular rosacea were previously demonstrated in two 12-week, Phase 3 studies. OBJECTIVE: We sought to evaluate the safety and efficacy of FMX103 1.5% foam for up to 52 weeks of treatment. METHODS: 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. RESULTS: 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. LIMITATIONS: Due to the nature of the open-label study, lacking a vehicle-treated control, no statistical comparisons can be made. CONCLUSION: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.
RCT Entities:
BACKGROUND: Efficacy and safety of FMX103 1.5% for papulopustular rosacea were previously demonstrated in two 12-week, Phase 3 studies. OBJECTIVE: We sought to evaluate the safety and efficacy of FMX103 1.5% foam for up to 52 weeks of treatment. METHODS: 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. RESULTS: 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. LIMITATIONS: Due to the nature of the open-label study, lacking a vehicle-treated control, no statistical comparisons can be made. CONCLUSION: 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.
Authors: James Q Del Rosso; Diane Thiboutot; Richard Gallo; Guy Webster; Emil Tanghetti; Lawrence F Eichenfield; Linda Stein-Gold; Diane Berson; Andrea Zaenglein Journal: Cutis Date: 2014-01
Authors: Andrea L Zaenglein; Arun L Pathy; Bethanee J Schlosser; Ali Alikhan; Hilary E Baldwin; Diane S Berson; Whitney P Bowe; Emmy M Graber; Julie C Harper; Sewon Kang; Jonette E Keri; James J Leyden; Rachel V Reynolds; Nanette B Silverberg; Linda F Stein Gold; Megha M Tollefson; Jonathan S Weiss; Nancy C Dolan; Andrew A Sagan; Mackenzie Stern; Kevin M Boyer; Reva Bhushan Journal: J Am Acad Dermatol Date: 2016-02-17 Impact factor: 11.527
Authors: M Schaller; H Schöfer; B Homey; M Hofmann; U Gieler; P Lehmann; T A Luger; T Ruzicka; M Steinhoff Journal: J Dtsch Dermatol Ges Date: 2016-12 Impact factor: 5.584
Authors: Kenshi Yamasaki; Kimberly Kanada; Daniel T Macleod; Andrew W Borkowski; Shin Morizane; Teruaki Nakatsuji; Anna L Cogen; Richard L Gallo Journal: J Invest Dermatol Date: 2010-11-25 Impact factor: 8.551