FALL CLINICAL 2018 IDP-121 Hispanic and Tolerability Novel Tretinoin 0.05% lotion for the once-daily treatment of moderate-to-severe acne vulgaris in a Hispanic population Fran E Cook-Bolden, MD1, Susan H Weinkle2, MD, Eric Guenin, PharmD, PhD3, Varsha Bhatt, PhD4 1Skin Specialty Dermatology and Department of Dermatology, Mount Sinai Hospital Center, New York, NY; 2 Dermatology, University of South Florida, Tampa, FL; 3Ortho Dermatologics, Bridgewater, NJ; 4Dow Pharmaceutical Sciences Inc., Petaluma, CA. . Presented at the Fall Clinical Dermatology Conference, October 18-21, 2018, Las Vegas, NV Background • Acne vulgaris (acne) is the most common dermatologic diagnosis seen in a Hispanic population • Despite their growing demographics in the US, there are few studies evaluating acne treatment in this population • Potential for skin irritation and dryness, as well as pigmentary changes are key concerns • A new lotion formulation of tretinoin has recently been developed leveraging polymerized emulsion technology with the aim to improve both efficacy and tolerability. Objective • To determine the efficacy and safety of tretinoin 0.05% lotion in treating moderate-to- severe acne in a Hispanic population. Methods • Post hoc analysis of two multicenter, randomized, double-blind, vehicle- controlled Phase 3 studies in moderate or severe acne • Hispanic subjects (aged 11 to 50 years, N=766) were randomized (1:1) to receive tretinoin 0.05% lotion or vehicle, once- daily for 12 weeks • CeraVe® hydrating cleanser and CeraVe® moisturising lotion (L’Oreal, NY) were provided for optimal moisturization/cleaning of the skin • Efficacy assessments included changes in baseline inflammatory and noninflammatory lesions and treatment success (at least 2-grade reduction in Evaluator’s Global Severity Score [EGSS] and clear/almost clear) • Safety, adverse events (AEs) and cutaneous tolerability were evaluated throughout. Supported by Ortho Dermatologics © 2018 All Rights Reserved Results • At Week 12, mean percent reduction in inflammatory and noninflammatory lesion counts were 60.1% and 53.0% respectively compared with 51.1% and 38.7% with vehicle (P£0.001) in the Hispanic population, Figures 1 and 2 • Treatment success was achieved by 19.6% of patients by Week 12, compared with 12.7% on vehicle (P=0.015), Figure 3 • The majority of AEs were mild and transient. There were four serious AEs (SAEs) reported (two each group) • The most frequently reported treatment related AEs with tretinoin 0.05% lotion were application site pain (2.0%), dryness (1.4%) and erythema (1.2%), Table 1 • Local cutaneous safety and tolerability assessments were generally mild-to- moderate at baseline and improved by Week 12 • Slight increases in mean scores were observed for scaling and burning within the first four weeks and appeared to be transient. Conclusion Tretinoin 0.05% lotion was significantly more effective than its vehicle in achieving treatment success and reducing inflammatory and noninflammatory acne lesions in a Hispanic population. The new lotion formulation was well- tolerated, and all treatment-related AEs were both mild and transient in nature. Figure 1: Percent Change in Inflammatory Lesions from Baseline to Week 12 in Hispanic Subpopulation (ITT population pooled data, LS Mean) Table 1: Treatment-Emergent and Related Adverse Event (AE) Characteristics through Week 12 (Pooled Data – Safety Population) HISPANICS Figure 3: Evaluator ’s Global Severity Scores. Patients with at least a 2-grade improvement and ‘clear ’ or ‘almost clear at each study visit Hispanic Subpopulation (ITT Population pooled data) Figure 2: Percent Change in Noninflammatory Lesions from Baseline to Week 12 Hispanic Subpopulation (ITT Population, LS Mean) Tretinoin 0.05% Lotion (N=345) Vehicle Lotion (N=379) Patients reporting any TEAE 47 (13.6%) 67 (17.7%) Patients reporting any SAE 2 (0.6%) 2 (0.5%) Patients who died 0 (0.0%) 0 (0.0%) Patients who discontinued due to TEAE 3 (0.9%) 0 (0.0%) Severity of AEs reported Mild 36 (10.4%) 42 (11.1%) Moderate 9 (2.6%) 19 (5.0%) Severe 2 (0.6%) 6 (1.6%) Relationship to study drug Related 15 (4.3%) 7 (1.8%) Unrelated 32 (9.3%) 60 (15.8%) Treatment Related AEs reported by ≥1% patients Application site pain 7 (2.0%) 0 (0.0%) Application site dryness 5 (1.4%) 1 (0.3%) Application site erythema 4 (1.2%) 0 (0.0%) -30% -47% -60% -28% -40% -51% -70% -60% -50% -40% -30% -20% -10% 0% Tretinoin 0.05% lotion (N=371) Vehicle (N=395) P e rc e n t ch an g e f ro m b as e lin e in m e an in fl am m at o ry le si o n s Baseline Week 4 Week 8 Week 12 *P=0.006 versus vehicle **P=0.001 versus vehicle * ** -26% -40% -53% -20% -29% -39% -60% -50% -40% -30% -20% -10% 0% Tretinoin 0.05% lotion (N=371) Vehicle (N=395) P e rc e n t ch an g e f ro m b as e lin e in m e an n o n in fl am m at o ry le si o n s Baseline Week 4 Week 8 Week 12 ** *** *P=0.006 versus vehicle **P=0.001 versus vehicle ***P<0.001 versus vehicle * 3% 7% 20% 3% 6% 13% 0% 5% 10% 15% 20% 25% 30% Week 4 Week 8 Week 12 Tretinoin 0.05% lotion (N=371) Vehicle (N=395) T re at m e n t S u cc e ss – p e rc e n t o f p at ie n ts w it h t w o g ra d e o r g re at e r r e d u ct io n in E G S S f ro m b as e lin e A N D ‘c le ar ’ o r ‘a lm o st c le ar ’ *P=0.015 versus vehicle *