ACKNOWLEDGEMENTS: Medical writing support was provided by Prescott Medical Communications Group (Chicago, IL) with financial support from Ortho Dermatologics; Ortho Dermatologics is a division of Bausch Health US, LLC • Presented at the 2022 Fall Clinical Dermatology Conference • October 20-23, 2022 • Las Vegas, NV SYNOPSIS � Truncal acne (occurring on the chest and back) is common among patients with facial acne,1-3 though its pathophysiology may be somewhat different4,5 � As there are no specific guidelines for the treatment of truncal acne, facial acne treatment guidelines are often the basis for its management3 � Successful treatment of truncal acne is complicated by the involvement of a large body surface area that is typically covered in clothing3 � Topical vehicles that provide ease of spreadability, rapid cutaneous penetration/effective drug delivery, and lack of residue are highly desirable for truncal acne treatment1 � A lower-dose tazarotene 0.045% lotion formulation (Arazlo®; Ortho Dermatologics) was developed utilizing polymeric emulsion technology (Figure 1)6 • This highly spreadable lotion formulation was developed to allow for more efficient delivery of tazarotene into dermal layers • In phase 1 studies, this lotion demonstrated low irritation/contact dermatitis potential and no allergic sensitization7 OBJECTIVES � To evaluate tazarotene 0.045% lotion on the trunk using three studies with distinct objectives: • Study 1: summarize the efficacy, safety, and tolerability of tazarotene 0.045% lotion in the treatment of truncal acne • Study 2: compare the irritation potential with repeated application of tazarotene 0.045% lotion and trifarotene 0.005% cream on the trunk • Study 3: evaluate the spreadability of tazarotene 0.045% lotion and trifarotene 0.005% cream on the trunk FIGURE 1. Polymeric Emulsion Technology for Tazarotene 0.045% Lotion 1-2 μm ① Polymeric matrix holds water and water-soluble hydrating agents within a 3-D mesh ② Droplets of tazarotene and oil-soluble moisturizing agents held apart by the 3-D mesh ③ 3-D mesh allows for uniform distribution of tazarotene and moisturizing agents STUDY 2: IRRITATION POTENTIAL Tazarotene 0.045% Lotion vs Trifarotene 0.005% Cream • Modi�ed cumulative irritancy patch test in 20 healthy adults (22–74 years; Fitzpatrick skin types I-II) • Patches loaded with tazarotene 0.045% lotion, trifarotene 0.005% cream, or control (no product) were applied to the upper back; patches replaced every 2–3 d for 12 d • After each patch removal, skin was assessed for dermal effects (eg, erythema, edema, papules) and other effects (eg, glazing, peeling, cracking) on a scale of 0 to 7 Study 2 Design A. Dermal Effects 0.0 1.5 2.0 2.5 3.0 Day 1 Day 3 Day 5 Day 8 M e a n S co re , D e rm a l R e sp o n se 1.0 Tazarotene 0.045% Lotion Trifarotene 0.005% Cream Control *P<0.05; **P<0.01; ***P≤0.001 vs tazarotene 0.045% lotion. #P<0.05; ##P<0.01; ###P<0.001 active drug vs control. • Over 12 days of exposure, tazarotene 0.045% lotion was associated with minimal irritation • Tazarotene 0.045% lotion was signi�cantly less irritating than trifarotene 0.005% cream 2 days after �rst patch application and continuing through day 12 0.5 Day 10 Day 12 3=Erythema and papules 2=De�nite erythema, readily visible; minimal edema/ papular response 1=Minimal erythema; barely perceptible B. Other Effects 0.0 1.5 2.0 2.5 3.0 Day 1 Day 3 Day 5 Day 8 M e a n S co re , O th e r E ff e ct s 1.0 0.5 Day 10 Day 12 3=Glazing with peeling and cracking 2=Marked glazing 1=Slight glazed appearance ### ### ## ***###***### ***### ***### *# ***###**### **###**## ******** Tazarotene 0.045% Lotion Trifarotene 0.005% Cream Control STUDY 3: SPREADABILITY Tazarotene 0.045% Lotion vs Trifarotene 0.005% Cream9 ***P<0.001 vs trifarotene 0.005% cream. • Double-blind split-body study of 30 healthy adults (18–59 years) • Each product (0.1 mL) was applied to a 10 cm wide area on one side of subjects’ backs and moved down the back until it would no longer spread; area of spread was then determined 160 0 40 80 120 167.0 Tazarotene 0.045% Lotion M e a n A re a o f P ro d u ct S p re a d ( cm 2 ) 130.3 200 Trifarotene 0.005% Cream Tazarotene 0.045% Lotion Trifarotene 0.005% Cream Mean Spreadability of Tazarotene Lotion and Trifarotene Cream (N=30) Subject example Mean difference: 36.7 cm2 • On average, skin coverage with tazarotene 0.045% lotion was ~30% greater than with trifarotene 0.005% cream Study 3 Design Tazarotene 0.045% Lotion for Truncal Acne: Efficacy, Tolerability, and Spreadability Leon H Kircik, MD1-3; Zoe D Draelos, MD4; Eric Guenin, PharmD, PhD, MPH5 1Icahn School of Medicine at Mount Sinai, New York, NY; 2Indiana University Medical Center, Indianapolis, IN; 3Physicians Skin Care, PLLC, DermResearch, PLLC, and Skin Sciences, PLLC, Louisville, KY; 4Dermatology Consulting Services, PLLC, High Point, NC; 5Ortho Dermatologics*, Bridgewater, NJ *Ortho Dermatologics is a division of Bausch Health US, LLC STUDY 1: EFFICACY, SAFETY, AND TOLERABILITY IN TRUNCAL ACNE Tazarotene 0.045% Lotion8 • Subjects aged ≥12 years • Moderate truncal acne (Investigator’s Global Assessment score = 3) • Once-daily treatment with tazarotene 0.045% lotion for 12 weeks • Age (mean): 24.1 years • Sex: 52.6% female • Race: 52.6% White, 36.8% Black, 10.5% Biracial Study 1 Design Demographics Total Lesion Reductions -100% -60% -40% -20% 0% Baseline Week 4 Week 8 Week 12 LS M e a n P e rc e n t C h a n g e F ro m B a se lin e -80% -44.9% *** Tazarotene 0.045% Lotion (n=19) -67.7% *** -82.3% *** LS mean percent changes from baseline: IL -49.4%*** -63.8%*** -83.3%*** NIL -7.6%* -59.3%** -64.3%** Cutaneous Tolerability and Safety 0% 40% 60% 80% 100% P e rc e n ta g e o f S u b je ct s 20% There were no adverse events related to tazarotene treatment in this study. BL, baseline. Clear/Almost Clear Skin 0% 40% 60% 80% 100% Baseline Week 4 Week 8 Week 12 P e rc e n ta g e o f S u b je ct s 20% *** 21% Tazarotene 0.045% Lotion (n=19) *** 47% *** 89% Truncal Ef�cacy *P<0.05; **P<0.01; ***P<0.001 vs baseline. IL, in�ammatory lesions; LS, least squares; NIL, nonin�ammatory lesions. Severity: None Trace Mild 11% 90% 100% Peeling BL 11% 16% 74% 5% 21% 74% Erythema 11% 90% 100% Dryness 95% 5% 95% Oiliness 5% 16% 84% 11% 5% 84% Pruritus 5% 95% 11% 5% 84% Burning At Week 12: • ~90% achieved clear or almost clear skin • >80% reductions from baseline in total lesion counts • Most subjects had no tolerability issues • There were no signi�cant changes from baseline to week 12 in any tolerability assessment Wk12 BL Wk12 BL Wk12 BL Wk12 BL Wk12 BL Wk12 CONCLUSIONS � Tazarotene 0.045% lotion utilizes polymeric emulsion technology to enhance hydration, moisturization, and skin barrier function � Tazarotene 0.045% lotion led to statistically significant reductions in truncal acne severity and lesion counts; ~90% of subjects achieved clear or almost clear skin with 12 weeks of once-daily use and most subjects had no tolerability issues � This easy-to-apply tazarotene lotion was associated with less irritation and ~30% greater skin coverage compared with trifarotene cream • Less product needed to cover the same skin area equals more applications per unit volume REFERENCES 1. Del Rosso JQ. Cutis. 2006;77:285–289. 2. Dréno B, et al. JEADV. 2015;29(6):1096–1106. 3. Poli F, et al. JEADV. 2020;34(10):2241–2246. 4. Short RW, et al. Pediatr Dermatol. 25(1):126–128. 5. Kim BR, et al. Dermatol. 231:87–93. 6. Tanghetti EA, et al. J Dermatol Treat. 2019;Sept 26:1–8. 7. Kircik LH, et al. J Dermatol Treat. 2021;Aug 30:1–9. 8. Kircik LH. J Drugs Dermatol. 2022;21(7):713–716. 9. Draelos ZD, et al. J Drugs Dermatol. 2021;21(3):250–257. AUTHOR DISCLOSURES Leon H Kircik has acted as an investigator, advisor, speaker, and consultant for Ortho Dermatologics. Zoe D Draelos received funding from Ortho Dermatologics to conduct the research presented here. Eric Guenin is an employee of Ortho Dermatologics and may hold stock and/or stock options in its parent company.