CE Arrowitz,1 LI Jiang,2 PD Hino,2 MJ Babcock,3 TM Weber1 1Beiersdorf Inc., Wilton, CT; 2Thomas J Stephens & Associates, Richardson, TX; 3Colorado Springs Dermatology Clinic, Colorado Springs, CO INTRODUCTION CONCLUSIONS REFERENCE OBJECTIVE METHODS A Comparison of Efficacy among Therapeutic Moisturizing Creams u Xerosis is a highly prevalent condition, with moisturizers being the mainstay of treatment1 u There are many available moisturizing cream formulations to choose from, which vary in composition and efficacy u Moisturization superiority can only be established from controlled, head-to-head comparative trial results u The two studies reported here compared a single moisturizing cream formulation versus two market-competitor formulations when used by subjects with dry skin on the lower legs RESULTS u All subjects enrolled completed the study (Table 1) u All three moisturizing creams significantly improved hydration of dry skin after 10 days of daily use; this was maintained for 5 days after treatment was discontinued u In Study 1, MCA demonstrated superiority to MCB in improving skin hydration as well as reducing skin flakiness due to dry skin u In Study 2, MCA significantly improved skin hydration compared with MCC at Day 10. Additionally, MCA improved TEWL significantly after 10 days compared with baseline, while MCC did not u These results suggest that MCA outperformed MCB and MCC in alleviating dry skin on the lower legs u These studies demonstrated that all three products would be suitable for the treatment of xerosis; however, MCA demonstrated superior efficacy as a therapeutic moisturizer 1. Draelos ZD. Cutis. 2013;91:308–314. u To compare the efficacy of three therapeutic moisturizers in improving dry skin u Two double-blind, comparative, split-body studies were conducted Study 1 Subjects u 35 subjects aged 18–65 years with mild to severe xerosis on lower legs Products u Eucerin Advanced Repair Cream (Beiersdorf Inc., Wilton, CT; Moisturizing Cream A [MCA]) u Cetaphil Moisturizing Cream (Galderma, Fort Worth, TX; Moisturizing Cream B [MCB]) Study 2 Subjects u 33 subjects aged 16–65 years with mild to severe xerosis on lower legs Products u Moisturizing Cream A (MCA) u CeraVe Moisturizing Cream (L’Oréal, New York, NY; Moisturizing Cream C [MCC]) Study design u Each subject served as their own comparator (split-body trial design) u Products were randomly assigned to each lower leg and applied once daily for 10 days u Subjects discontinued product use at Day 10 and participated in a 5-day regression phase Assessments u Expert clinical grading (dryness, roughness, flaking), skin hydration, and transepidermal water loss (TEWL) at baseline, Day 10, and regression Day 5 – Clinical grading used a scale of 0 (none) to 9 (severe) u Clinical grading parameters were statistically tested using Wilcoxon signed-rank test; Corneometer and TEWL comparisons were tested using paired t-test Sponsorship: Research sponsored by Beiersdorf Inc., Wilton, CT Regression phase (5 days) Treatments applied daily (10 days) Treatment discontinued Baseline Day 10 R Day 5Assessments Table 1. Baseline demographics Study 1 (n=35) Study 2 (n=33) Sex, n (%) Female 23 (65.7) 21 (63.6) Male 12 (34.3) 12 (36.4) Fitzpatrick skin type, n (%) I 10 (28.6) 0 II 2 (5.7) 7 (21.2) III 4 (11.4) 17 (51.5) IV 18 (51.4) 4 (12.1) V 1 (2.9) 5 (15.2) 0 20 40 60 80 100 Day 10 R Day 5 0 20 40 60 80 100 Day 10 R Day 5 Study 1 Study 2 a,c a a b a,c a a a,d M e a n c h a n g e f ro m b a se li n e ( % ) M e a n c h a n g e f ro m b a se li n e ( % ) MCA MCB MCA MCC ap<0.001 vs baseline; bp=0.003 vs baseline; cp<0.001 in favor of MCA; dp=0.009 in favor of MCA Figure 1. Skin hydration improvement at Day 10, and 5 days after completion of treatment (regression Day 5) Skin hydration measured using a Corneometer 0 1 2 3 4 5 6 Baseline Day 10 R Day 5 Baseline Day 10 R Day 5 Baseline Day 10 R Day 5 Baseline Day 10 R Day 5 Baseline Day 10 R Day 5 Baseline Day 10 R Day 5 0 1 2 3 4 5 6A. Dryness B. Roughness C li n ic a l g ra d in g s co re C li n ic a l g ra d in g s co re a a a a a a aa 0 1 2 3 4 5 6 MCA MCB MCA MCC C. Flaking C li n ic a l g ra d in g s co re a,b a a,b a 0 1 2 3 4 5 6 0 1 2 3 4 5 6 D. Dryness E. Roughness Study 1 Study 2 C li n ic a l g ra d in g s co re C li n ic a l g ra d in g s co re a a a a,b a a a a 0 1 2 3 4 5 6 F. Flaking C li n ic a l g ra d in g s co re a a a,b a ap<0.001 vs baseline; bp≤0.01 vs MCB ap≤0.001 vs baseline; bp≤0.01 vs MCC Figure 3. Clinical grading of dryness (A, D), roughness (B, E), and flaking (C, F) Symptoms were graded on a 0–9 scale (0 = none, 9 = severe) at baseline, Day 10, and 5 days after completion of treatment (regression Day 5). R, regression −8 −7 −6 −5 −4 −3 −2 −1 0 Day 10 R Day 5 −12 −10 −8 −6 −4 −2 0 Day 10 R Day 5 Study 1 Study 2 a M e a n c h a n g e f ro m b a se li n e ( % ) M e a n c h a n g e f ro m b a se li n e ( % ) ap<0.05 vs baseline MCA MCB MCA MCC Figure 2. Transepidermal water loss (TEWL) improvement at Day 10, and 5 days after completion of treatment (regression Day 5) Increased TEWL is an indication of a disrupted barrier function; decreased TEWL indicates improvement in barrier function. R, regression; TEWL, transepidermal water loss u Corneometer results indicated that all three test products statistically improved skin hydration after 10 days of daily use (Figure 1) u MCA showed statistically greater improvements in skin hydration compared with MCB and MCC at Day 10, and compared with MCB 5 days after discontinuation of product u In Study 1, no significant changes in TEWL were observed for either MCA or MCB at either time point (Figure 2) u MCA significantly improved TEWL after 10 days compared with baseline in Study 2. MCC did not significantly improve TEWL relative to baseline (Figure 2) u Clinical grading in Study 1 demonstrated that both MCA and MCB significantly improved dryness, roughness, and flaking of the lower legs after 10 days, which was maintained 5 days after discontinuation of treatment (p<0.001) (Figure 3 A–C) u MCA significantly improved flaking compared with MCB (p<0.05) u Clinical grading in Study 2 showed that both MCA and MCC significantly improved all three parameters from baseline and maintained these improvements 5 days after discontinuation (p≤0.001) (Figure 3 D–E) u MCA showed significantly greater maintenance of improvements in dryness and flaking at regression Day 5 compared with MCC (p<0.01)