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ePoster 1241 A Randomized Controlled Clinical Study to Evaluate the Effectiveness of an Active Moisturizing Lotion with Colloidal Oatmeal Skin Protectant Versus Its Vehicle for the Relief of Xerosis aAmer N. Kalaaji, MD; bWarren Wallo, MS a Mayo Clinic Department of Dermatology, Rochester, MN bScientific Affairs Department, Johnson & Johnson Consumer Products Company, Skillman, NJ Research supported by a grant from Johnson & Johnson CCI. ©2015 MFMER | slide-1 Disclosures • The research was funded by a grant from Johnson & Johnson CCI. • Dr. Kalaaji has no relevant conflicts of interest to declare. • Mr. Wallo was an employee of Johnson & Johnson at the time of the research. ©2015 MFMER | slide-2 Abstract • Background: Xerosis is a common skin condition, resulting in loss of moisture, cracking, and desquamation. • Objective: To compare a commercially available moisturizing product against its own vehicle in patients with bilateral xerosis of the lower legs • Methods: Subjects applied product or vehicle twice daily in a randomized, bilateral design over a three week period, followed by one week of regression. Dermatological assessments, objective instrumental biophysical measurements and patient self-assessments were performed at baseline, 3 weeks, and after 1 week regression. • Results: 30 female subjects completed the study. The active moisturizing lotion had significantly greater improvements from baseline than the vehicle for scaling, overall dryness, as well as intensity, duration, and frequency of itch. The active moisturizing lotion demonstrated significantly better hydration as measured by the Corneometer and SkiCon instrumentation at 21 and again at 28 days. Patients favored the active moisturizing lotion. • Conclusions: The active ingredients in the moisturizing lotion are more effective than the vehicle. ©2015 MFMER | slide-3 Methods • Clinical evaluations: • Test sites on the lower legs of each of the subjects were graded at baseline (Visit 1, day 0), after 21 days of treatment (Visit 2), and after one week regression without treatment (Visit 3, day 28). • Scaling was graded on a scale of 0-9. • Overall dryness was evaluated using a 0-4 scale. • The intensity, duration and frequency of their itch on a 0-3 scale. ©2015 MFMER | slide-4 Methods • Instrumental measurements: • Corneometer and the SkiCon instruments were used to quantify moisture content in the stratum corneum by an electrical method. • Three replicate measurements were taken on each lower lateral leg midpoint between the knee and ankle at each of the three visits. ©2015 MFMER | slide-5 Methods • Self Assessment: • Subjects completed a self assessment questionnaire at Baseline (Day 0), Day 21, and Day 28. • Subjects rated the condition of the skin on each of their lower legs and expressed their preferences as to which product was more effective for a number of parameters. ©2015 MFMER | slide-6 Methods • Statistical analysis: • Mean difference between products were compared using paired t-tests. Changes from baseline for a product were tested using paired t-tests. Proportions were compared using McNemar’s test. Preferences were tested using the binomial test. • P<0.05 was considered statistically significant. ©2015 MFMER | slide-7 Results • Clinical evaluations • After 21 days of treatment, the changes from baseline value for the parameters of scaling and overall dryness were significantly greater for the active moisturizer than its vehicle (P=0.03 and P=0.004, respectively). ©2015 MFMER | slide-8 Results • Clinical evaluations • The active moisturizer was perceived as better at relieving itch than the vehicle alone. ©2015 MFMER | slide-9 Results • Instrumental measurements • At day 21 and day 28, the measurements were significantly higher (P<0.05) for the active moisturizing lotion than the vehicle, indicating better hydration. • The average change in moisturization was significantly greater (P<0.05) for the active moisturizing lotion than the vehicle. • There was also a considerable decrease in hydration for both lotions during the regression phase. ©2015 MFMER | slide-10 Results • Instrumental measures Measurements with the Corneometer. Measurements with the SkiCon The active moisturizing lotion (white bars) is compared with the vehicle (black bars). A larger number indicates more hydration. The active moisturizing lotion (white bars) is compared with the vehicle (black bars). A larger number indicates more hydration. ©2015 MFMER | slide-11 Results • Videomicroscopic images • Example from one patient shows xerosis at baseline (A). • After 21 days of treatment (B), the leg treated with the active moisturizing lotion showed marked improvement over the leg treated with the vehicle. • Even after the 1-week regression period (C), the area treated with the active moisturizing lotion still displayed fewer signs of xerosis than the area treated with the vehicle. ©2015 MFMER | slide-12 Results • Self-Assessment of Patient Preferences ©2015 MFMER | slide-13 Conclusions • Blinded clinical grading demonstrated that the active moisturizing lotion had greater statistical improvements from baseline compared to the vehicle for the parameters of scaling, overall dryness as well as the intensity, duration and frequency of itch. • The active moisturizing lotion demonstrated significantly better hydration as measured by the Corneometer and SkiCon both at 21 days and again at 28 days (after the 1 week regression). ©2015 MFMER | slide-14 Conclusions • The patient self-assessments also demonstrated that patients favored the active moisturizing lotion on almost all tested attributes. • There is value in having clear evidence-based results available for a dermatologist showing the active ingredients in a skin care product have the actual effect promised and are more effective than vehicle. ©2015 MFMER | slide-15 References 1. Moses S. Pruritus. Am Fam Physician. 2003; 68(6):1135-42. 2. Berger TG, Shive M, Harper GM. Pruritus in the older patient: a clinical review. JAMA 2013;310(22):2443-50. 3. Kurtz ES, Wallo W. Colloidal oatmeal: history, chemistry and clinical properties. J Drugs Dermatol 2007;6:167-70. 4. Eichenfield LF, Flwler JF Jr, Rigel DS, Taylor SC. Natural advances in eczema care. Cutis 2007;80:2-16. 5. Draelos ZD. Modern moisturizer myths, misconceptions, and truths. Cutis 2013;91:308-14. ©2015 MFMER | slide-16