20201214_Sugarman_elderly EFFICACY OF MICROENCAPSULATED BENZOYL PEROXIDE (E-BPO) CREAM, 5% IN ELDERLY ROSACEA PATIENTS J Sugarman,¹ H Baldwin,² N Bhatia³ 1. University of California - San Francisco, San Francisco, CA; 2. Acne Treatment & Research Center, Brooklyn, NY; 3. Therapeutics Research Inc, San Diego, CA To interact with and explore these data more intimately, please click here: https://www.solgelposters.com INTRODUCTION • In a new microencapsulated formulation (E-BPO Cream, 5%), the drug is entrapped in silica microcapsules. This extends drug delivery time to improve efficacy and reduce the potential for skin irritation.1 • The efficacy, safety, and tolerability of E-BPO Cream, 5% were evaluated in two identical randomized, double-blind phase 3 trials which demonstrated significant superiority of E-BPO versus vehicle for percentage of patients achieving success (clear or almost clear) on the Investigators Global Assessment (IGA) and reducing the number of lesions.2 • E-BPO Cream, 5% was also well tolerated with adverse events (AEs) and cutaneous safety and tolerability comparable to that for vehicle.2 • The prevalence of rosacea is higher in the elderly population than the general population,3,4 but no quantitative data has been published regarding treatment efficacy on papulopustular rosacea in this subpopulation. This report summarizes results from an analysis of younger (<65 years of age) and more elderly (≥65 years old) patients who were included in the two trials of E-BPO Cream, 5%. RESULTS Patients • A total of 733 patients were enrolled, including 493 who were treated with E-BPO Cream, 5% and 240 who received Vehicle Cream (VC). • There were 606 patients <65 years old who were enrolled in the trial and 127 patients who were ≥65 years of age. Efficacy • The analysis indicated that E-BPO Cream, 5% was significantly superior to VC for achievement of IGA success and reduction in inflammatory lesions in both age groups. • Results for all patients indicated that IGA success was achieved in 48.3% of patients who received E-BPO Cream, 5% vs 24.5% for VC. The respective values for patients <65 years of age were 45.7% and 23.8% and those for patients ≥65 years old were 60.0% and 28.1% (Figure 1). • Results for all patients indicated that the absolute reduction from baseline in inflammatory lesions was –19.2 for patients who received E-BPO Cream, 5% vs –11.0 for VC. The respective values for patients <65 years of age were –19.6 and –11.2 and those for patients ≥65 years old were –17.5 and –10.4 (Figure 2) (all P<0.001). METHODS Patients Safety and Tolerability • The safety and tolerability of E-BPO Cream, 5% was comparable to VC in both age groups (Table 1). • 733 patients ≥18 years old with moderate or severe disease (IGA grade 3 or 4, ≥15 inflammatory lesions, ≤2 nodules) were randomized (2:1) to once-daily E-BPO Cream, 5% (n=493) or Vehicle Cream (n=240) for 12 weeks. ASSESSMENTS • Clinical evaluations were performed at weeks 2, 4, 8, and 12. The primary efficacy endpoints were the proportion of patients with the primary measure of success: “Clear” (0) or “Almost clear” (1) in the IGA relative to baseline at week 12 and absolute change from baseline in inflammatory lesion count at week 12. • Secondary endpoints include success in both parameters at weeks 2, 4, and 8. • All analyses were carried out on the intent-to-treat population. • Adverse events were also recorded and are presented for the safety population. 733 patients / ≥18 years / 12 weeks ACKNOWLEDGMENTS: The authors wish to recognize the support of Robert Rhoades, PhD, and Thomas Prunty, CMPP, of AraMed Strategies, LLC., for their editorial and scientific analysis support. Their assistance was funded along with the studies represented herein, by Sol-Gel Technologies, Ltd. REFERENCES: 1. Erlich M, Arie T, Koifman N, Talmon Y. Structure elucidation of silica-based core-shell microencapsulated drugs for topical applications by cryogenic scanning electron microscopy. J Colloid Interface Sci. 2020;579:778-785. 2. Bhatia N, Werschler W, Sugarman J Stein Gold L. Efficacy and safety of microencapsulated benzoyl peroxide cream, 5% in papulopustular rosacea: Results from two phase 3, vehicle-controlled trials. 2020. In Submission. 3. Tan J, Schöfer H, Araviiskaia E, Audibert F, Kerrouche N, Berg M; RISE study group. Prevalence of rosacea in the general population of Germany and Russia - The RISE study. J Eur Acad Dermatol Venereol. 2016;30:428-434. 4. Sinikumpu SP, Jokelainen J, Haarala AK, Keränen MH, Keinänen-Kiukaanniemi S, Huilaja, L. The high prevalence of skin diseases in adults aged 70 and older. J Am Geriatr Soc. 2020; 68:2565-2571. CONCLUSIONS This combined analysis of results from the two phase 3, randomized, double-blind controlled studies of E-BPO Cream, 5% indicate that it was efficacious in both older and younger patients with papulopustular rosacea. Figure 1. Percentage of patients achieving of IGA success at 12 weeks of active treatment Figure 2. Reductions in inflammatory lesions from baseline to 12 weeks of treatment Table 1. Safety summary Age <65 years Age ≥ 65 years Event E-BPO (N=398) % Vehicle (N=198) % E-BPO (N=90) % Vehicle (N=36) % Any Treatment-Emergent Adverse Event 19.3 17.7 24.4 11.1 Any Serious Treatment- Emergent Adverse Event 0 0 1.1 2.8 Deaths 0 0 0 0 Discontinued Study Drug Due to a Treatment-Emergent Adverse Event 2.0 1.0 3.3 2.8 Severe Treatment-Emergent Adverse Event 0.8 0 1.1 0 Drug-Related Treatment- Emergent Adverse Event 4.3 1.5 6.7 0 E-BPO (N=398) % Vehicle (N=198) % E-BPO (N=90) % Vehicle (N=36) % Nasopharyngitis 2.3 2.0 3.3 0 Application Site Pain 2.3 1.0 2.2 0 Application Site Erythema 1.8 1.0 4.4 0 Application Site Pruritus 1.0 0.5 2.2 0 Wrist Fracture 0 1.5 2.2 0 Femur Fracture 0 0 0 2.8 Diarrhea 0 0 2.2 0 25.5% 23.8% 28.1% 0% 20% 10% 40% 30% 60% 50% Age All <65 70% P er ce nt o f su bj ec ts ac hi ev in g IG A s uc ce ss a t w ee k 12 E-BPO (n= 493) Vehicle (n= 240) E-BPO (n= 403) Vehicle (n= 203) E-BPO (n= 90) Vehicle (n= 37) 48.3% 45.7% 60.0% P<0.0001 P<0.0001 ≥65 P=0.0009 -11.0 -11.2 -10.4 Age 0 -2 -4 -6 -8 -10 -12 -14 -16 -18 -20 E-BPO (n= 493) Vehicle (n= 240) E-BPO Vehicle (n= 403) (n= 203) E-BPO (n= 90) Vehicle (n= 37) All <65 ≥65 -19.2 -19.6 -17.5 P<0.0001 P<0.0001 P=0.009 M ea n re du ct io n in in fla m m at or y le si on co un t fr om b as el in e at W ee k1 2 60% of patients ≥65 years of age achieved IGA success at week 12 with E-BPO Cream, 5% EFFICACY OF MICROENCAPSULATED BENZOYL PEROXIDE (E-BPO) CREAM, 5% IN ELDERLY ROSACEA PATIENTS