Sol-Gel Technologies Phase 2 data on TWIN and VERED to be presented
Sol-Gel Technologies announced that data will be presented from the company's Phase 2 clinical trial for TWIN in the treatment of acne and also from its Phase 2 clinical trial for VERED in the treatment of subtype II rosacea at the 2018 American Academy of Dermatology Annual Meeting taking place February 16-20 in San Diego, California.The TWIN Phase 2 trial was a six-arm, randomized, double-blind, placebo-controlled clinical trial that enrolled 726 subjects at 36 sites in the United States. The trial evaluated the efficacy, tolerability and safety of two TWIN concentrations, TWIN High and TWIN Low, containing a higher or lower concentration of encapsulated tretinoin and an identical concentration of encapsulated benzoyl peroxide. Each of tretinoin and benzoyl peroxide, the two active components in TWIN, are widely used single agent therapies for acne that historically have not been conveniently co-administered. The trial also evaluated the separate active components of TWIN; both the higher and lower concentrations of encapsulated tretinoin and encapsulated benzoyl peroxide administered as a single agent. In this trial, TWIN showed statistically significant improvements in all pre-defined co-primary and secondary efficacy endpoints, as compared to vehicle. TWIN also exhibited favorable efficacy results compared to its active components. TWIN demonstrated excellent cutaneous tolerability with no treatment-related serious adverse events. The VERED Phase 2 was a multi-center, three-arm, randomized, double-blind, placebo-controlled study designed to assess the efficacy, tolerability and safety of two VERED concentrations, VERED 1% (encapsulated benzoyl peroxide 1%) and VERED 5%. A total of 92 subjects were enrolled in the trial at ten sites in the United States. Subjects were equally randomized into three separate arms: VERED 1%, VERED 5% and vehicle and each group received a once-daily dose. VERED showed statistically significant improvements in the IGA pre-defined co-primary efficacy endpoint and in the percent change in inflammatory lesion count at week 12, as compared to vehicle. VERED was also well tolerated in the trial.