ACKNOWLEDGEMENTS Study funded by Galderma R&D; poster/editorial support provided by Galderma Laboratories, L.P. INTRODUCTION Facial skin of those with rosacea is characterized by chronic barrier disruption that results in increased sensitivity, especially to many skincare products. Regular use of a moisturizer by patients with rosacea can help alleviate skin dryness and restore skin barrier function. However, care must be taken by this population to ensure selected products do not cause further irritation and potentially induce rosacea flares. A facial moisturizer designed for night time use has been specifically developed for patients with redness-prone skin (Cetaphil Night Moisturizer [CNM]). This formula is fragrance free and contains ingredients to help moisturizer and restore barrier function such as ceramide NP, vitamin E, allantoin, and licorice root extract among others. The results of 2 clinical studies that assessed the efficacy and tolerability of CNM are presented here. SUBJECTS and METHODS Study 1: Hydration and Skin Barrier Function • Men and women with dry volar forearms • Inner forearms randomized to treated and control • 40 mg of product applied to 20 cm2 - Corneometer and transepidermal water loss (TEWL) assessed at baseline and 2, 4, 8, and 24 hours Study 2: In Use Efficacy and Tolerability • Men or women with rosacea and mild to moderate non-transient erythema • Product applied QD in the evening for 3 weeks • Assessments made on day 1 before application, day 1 30 minutes after first use and days 8, and 22 before product application - Objective (chromameter) and subjective (investigator and subject) assessment of redness - Investigator and subject tolerability assessments · Redness and tolerability assessments made on a 5 point scale of 0 (none), 0.5 (very slight), 1 (slight), 2 (moderate) and 3 (strong) - Subject satisfaction PERFORMANCE OF A FACIAL NIGHT MOISTURIZER DESIGNED FOR REDNESS-PRONE SKIN Matthew H Meckfessel, PhD1; Sandrine Teissedre, MSc2; Nadege Lachmann3; Francine Santoro, MD3 1Galderma Laboratories, L.P., Fort Worth, Texas; 2Galderma R&D, Sophia Antipolis, France; 3Galderma R&D, Egerkingen, Switzerland CET.P-RD105328-01 SUMMARY CNM significantly improves skin hydration and skin barrier function and is an ideal nightly facial moisturizer for patients with rosacea RESULTS Skin hydration and skin barrier function significantly improved for 24 and 8 hours, respectively, compared to untreated and baseline (Figures 1 and 2). For the in use study, 33 women enrolled and completed the study with a mean age of 54.4 years. There was a significant improvement of erythema during the study as assessed by investigators and subjects (Figure 3). However, this change was not confirmed by instrumental measurement with the chromameter and is not clinically relevant (data not shown). The product was well tolerated with mean scores for all parameters less than mild (data not shown). Subjects demonstrated high satisfaction with the product (Figure 4). One mild adverse event of diarrhea was reported and was considered unrelated by the investigator. M ea n Co rn eo m et er (a .u .) CNM Control Area Hour 0 20 25 30 35 40 45 50 55 60 4 8 12 16 20 24 * * * *P < .05 vs baseline * M ea n Sc or e Investigator Subject Baseline Baseline, 30 Minutes Day 8 Day 22 0 1 2 3 *P < .05 vs baseline * * * * Disagree Neutral Agree Percent of Subjects Overall, I like the product very much Feel my skin is nourished Suitable for sensitive skin Leaves skin soft and smooth 0 50 6010 20 30 40 70 80 90 21.2 66.7 12.1 9.1 78.8 12.7 9.1 84.8 6.1 9.1 75.8 12.1 P < .05 for Agree vs Disagree for all * * * M ea n TE W L (g /m 2h ) Hour 0 0 2 4 6 8 10 4 8 12 16 20 24 CNM Control Area *P < .05 vs baseline Figure 4. Subject Satisfaction with CNM (n=33) Figure 1. Corneometry Assessments Figure 2. TEWL Assessments Figure 3. Investigator and Subject Assessed Skin Redness (n=33) FC17PosterGaldermaMeckfesselFacialNightMoisturizer.pdf