ACKNOWLEDGEMENTS: Medical writing support was provided by Prescott Medical Communications Group (Chicago, IL) with financial support from Ortho Dermatologics | Presented at the Fall Clinical Dermatology Conference • October 17-20, 2019 • Las Vegas, NV SYNOPSIS ◾ Quality of life (QoL) in patients with acne has been shown to correlate more strongly with patient-reported severity than physician-reported severity, suggesting that patient perception may be important to consider during acne treatment1 ◾ In acne patients, the psychosocial impacts are greater compared with other dermatologic conditions, particularly with feelings of despair and distress2 ◾ The first lotion formulation of tretinoin was developed by utilizing novel polymeric emulsion technology to provide an important alternative option to treat acne patients3 ◾ In two phase 3 studies (NCT02932306, NCT02965456), tretinoin 0.05% lotion was shown to be highly effective and well tolerated in patients with moderate-to-severe acne4 OBJECTIVE ◾ To evaluate if improvements in QoL with tretinoin 0.05% were correlated with improvements in acne symptoms METHODS ◾ QoL data from two multicenter, randomized, double-blind, vehicle-controlled studies were pooled in this post hoc analysis ◾ Participants with moderate or severe acne were randomized (1:1) to receive tretinoin 0.05% lotion or vehicle, once-daily for 12 weeks ◾ In these studies, CeraVe® hydrating cleanser and CeraVe® moisturizing lotion (L’Oreal, NY) were provided as needed for optimal moisturization/cleaning of the skin ◾ QoL was assessed using the validated Acne-QoL questionnaire in 4 different domains: self-perception, social, emotional, and acne symptoms • The correlation between the acne symptom domain (which represents the severity of acne) and the other three domains was assessed • Higher scores for each domain reflect improved health-related QoL, with the acne symptom domain score correlating inversely with acne severity (ie, higher score = improvement in acne symptoms) RESULTS ◾ The pooled population included 1640 participants (tretinoin, n=819; vehicle, n=821), 909 (55.4%) of whom were female; participants’ ages ranged from 9 to 58 years ◾ Mean changes from baseline to Week 12 in Acne-QoL domain scores indicated greater improvements with tretinoin 0.05% vs vehicle: self-perception (7.4 vs 6.7); role-emotional (6.8 vs 6.0); role-social (4.8 vs 4.6); and acne symptoms (6.5 vs 5.6) ◾ There was a significant correlation between improvements in acne symptoms and the other 3 QoL domains at baseline and at Week 12 (P<0.001) • The correlation between the acne symptom scores and the other domains was similar at baseline, with a Pearson’s correlation of 0.69 for self-perception (Figure 1) and role-emotional (Figure 2) and 0.68 for role-social (Figure 3) • At Week 12, correlations were similar (0.66, 0.67, and 0.61, respectively) with clear improvements seen with tretinoin treatment (Figures 1, 2, and 3 [higher scores for each domain vs baseline]) FIGURE 1: Correlation Between Acne Symptoms and Self-Perception at Baseline and Week 12 in Patients Treated With Tretinoin 0.05% Lotion (ITT population; Pooled Data) 5 4 3 2 1 0 6 5 4 3 2 1 0 6 S e lf -P e rc e p ti o n ( A ve ra g e S co re ) Im p ro ve m e n t 0 1 2 3 4 5 6 Acne Symptoms (Average Score) Improvement A. Baseline S e lf -P e rc e p ti o n ( A ve ra g e S co re ) Im p ro ve m e n t 0 1 2 3 4 5 6 Acne Symptoms (Average Score) Improvement B. Week 12 correlation=0.69 correlation=0.66 Higher scores for each domain reflect improved health-related QoL. ITT, intent-to-treat. FIGURE 2: Correlation Between Acne Symptoms and Role-Emotional at Baseline and Week 12 in Patients Treated With Tretinoin 0.05% Lotion (ITT population; Pooled Data) 5 4 3 2 1 0 6 5 4 3 2 1 0 6 R o le -E m o ti o n a l (A ve ra g e S co re ) Im p ro ve m e n t 0 1 2 3 4 5 6 Acne Symptoms (Average Score) Improvement A. Baseline R o le -E m o ti o n a l (A ve ra g e S co re ) Im p ro ve m e n t 0 1 2 3 4 5 6 Acne Symptoms (Average Score) Improvement B. Week 12 correlation=0.69 correlation=0.67 Higher scores for each domain reflect improved health-related QoL. ITT, intent-to-treat. FIGURE 3: Correlation Between Acne Symptoms and Role-Social at Baseline and Week 12 in Patients Treated With Tretinoin 0.05% Lotion (ITT population; Pooled Data) 5 4 3 2 1 0 6 5 4 3 2 1 0 6 R o le -S o ci a l (A ve ra g e S co re ) Im p ro ve m e n t 0 1 2 3 4 5 6 Acne Symptoms (Average Score) Improvement A. Baseline R o le -S o ci a l (A ve ra g e S co re ) Im p ro ve m e n t 0 1 2 3 4 5 6 Acne Symptoms (Average Score) Improvement B. Week 12 correlation=0.68 correlation=0.61 Higher scores for each domain reflect improved health-related QoL. ITT, intent-to-treat. CONCLUSIONS ◾ Improvements in acne symptoms scores correlated with improvements in the other QoL domains; these correlations were observed following 12 weeks of treatment with tretinoin 0.05% lotion ◾ These findings suggest the improvements seen in acne symptoms are associated with improvements in other measures of QoL REFERENCES 1. Martin AR, et al. Clin Exp Dermatol. 2001;26(5):380-385. 2. Gorelick J, et al. J Dermatol Nurses Assoc. 2015;7(3):154-162. 3. Kircik LH, et al. J Drugs Dermatol. 2019;18(4):s148-154. 4. Tyring SK, et al. J Drugs Dermatol. 2018;17(10):1084-1091. AUTHOR DISCLOSURES Dr. Heather Woolery-Lloyd is a shareholder for Somabella Laboratories, LLC. She has served as a speaker for Aclaris and Ortho Dermatologics, consultant for Ortho Dermatologics, and received grants/research funding from Allergan, Galderma, Nestle, Pfizer, Endo, LEO Pharma, Eirion, Golgel, and Aclaris. Dr. Julie Harper has received honoraria from Aclaris, Almirall, BioPharmX, Cassiopea, Cutanea, Dermira, Foamix, Galderma, LaRoche-Posay, Ortho Dermatologics, and Sun. Dr. Eric Guenin is an employee of Ortho Dermatologics. Acne-Related Quality of Life: Correlation Between Acne Symptom Scores and Other Domains Following Treatment with Tretinoin 0.05% Lotion Heather C Woolery-Lloyd, MD1; Julie C Harper, MD2; Eric Guenin, PharmD, PhD, MPH3 1Department of Dermatology and Cutaneous Surgery, University of Miami Miller School of Medicine, Miami, FL; 2Dermatology & Skin Care Center of Birmingham, Birmingham, AL; 3Ortho Dermatologics, Bridgewater, NJ