ACKNOWLEDGEMENTS Study funded by Galderma R&D; poster/editorial support provided by Galderma Laboratories, L.P. INTRODUCTION Cleansing skin is an important component of maintaining healthy skin as it removes dirt, oil, make up, and helps prepare the skin for topical prescription treatments. However, it can also damage the skin by stripping out natural moisturizing factors and degrading skin barrier function. For patients with rosacea, this is of particular concern due to underlying skin barrier disruption and increased skin sensitivity to many ingredients found in cleansing products. A foaming cleanser has been specifically developed for redness-prone skin (Cetaphil Foaming Face Wash [CFFW]). This formula contains caffeine, allantoin, and glycerin to help preserve the skin barier. The results of 2 clinical studies that assessed the performance and tolerability of CFFW are presented in this poster. SUBJECTS and METHODS Study 1: Hydration and Skin Barrier Function • Men and women with dry volar forearms • Product massaged onto pre moistened skin and left for 1 minute • Product was rinsed with 50 mL of warm water and blotted dry - Control had same rinsing and drying procedures • Corneometer and transepidermal water loss (TEWL) assessed at baseline and 2, 4, 8, and 24 hourss Study 2: In Use Efficacy and Tolerability • Men or women with rosacea and mild to moderate non-transient erythema • Product used BID for 3 weeks • Assessments made on day 1, day 1 30 minutes after first use and days 8 and 22 before product use - Chromameter, investigator, and subject assessment of redness - Investigator and subject tolerability (dermatologic and ophthalmologic) 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 AN EFFECTIVE YET GENTLE FOAMING FACIAL CLEANSER SPECIFICALLY 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-RD105309-01 SUMMARY CFFW provides effective, yet gentle cleansing, and is an ideal facial cleanser for patients with rosacea M ea n Sc or e (a .u .) Chromameter Baseline Day 1, 30 Minutes Day 8 Day 22 0 10 5 15 20 25 * *P < .05 vs baseline Figure 4. Chromameter Assessment Disagree Neutral Agree Percent of Subjects Overall, I like the product very much Is suitable for sensitive skin Washes away face make up and skin impurities Rinses easily to leave skin soft and clean 0 50 6010 20 30 40 70 80 90 100 24.2 69.7 66.7 3.0 3.0 3.0 3.0 21.2 9.1 15.2 78.8 90.9 P < .05 for Agree vs Disagree for all Figure 5. Subject Satisfaction RESULTS There were no significant changes to skin hydration or skin barrier function during the 24 hour period showing CFFW did not disrupt the skin barrier (Figures 1 and 2). For the in use study, 33 women enrolled with a mean age of 52.1 years. There was no significant change during the study as assessed by investigators and subjects (Figure 3). There was a significant worsening as assessed by chromameter at day 8 (Figure 4). However, this change in erythema is likely not clinically relevant as they were not noted by the investigator or subjects. The product was well tolerated with mean scores for all parameters less than mild for both dermatologic and ophthalmologic assessments (data not shown). Subjects demonstrated high satisfaction with the product (Figure 5). Three adverse events were reported and were not considered related by the investigator: toothache, suspicion of nervous breakdown, and edema of both lower lids. M ea n Co rn eo m et er (a .u .) CCFW Control Area Hour 0 20 22 24 26 28 30 32 34 36 38 40 4 8 12 16 20 24 No significant differences between control and CFFW M ea n TE W L (g /m 2h ) CCFW Control Area Hour 0 0 2 4 6 8 10 4 8 12 16 20 24 No significant differences between control and CFFW M ea n Sc or e Investigator Subject Baseline Day 1, 30 Minutes Day 8 Day 22 0 1 2 3 No significant differences from baseline. Figure 2. TEWL Assessments Figure 1. Corneometry Assessments Figure 3. Skin Redness Assessments FC17PosterGaldermaMeckfesselEffectiveFoamingCleanser.pdf