BACKGROUND: Dry, flaky skin remains one of the most common and vexing of human disorders. The anterior shin is a challenging area to treat in women with scaly skin. OBJECTIVE: We sought to investigate whether a lactic acid/ceramide lotion improves the texture and appearance of dry skin through moisturization and desquamation. METHODS: This was a randomized, single-center, controlled, evaluator-blinded, within-subject comparison of a lactic acid/ceramide lotion versus no treatment. The lotion was applied twice daily for 14 days, with evaluations performed on Days 1, 2, and 14. A total of 56 healthy female subjects, older than 50 years of age, with Fitzpatrick Skin Types I through VI and dry, rough skin on the anterior shins (defined as Grades 3-4 by investigator evaluation) were included in the study. Assessments of change in skin appearance following desquamation and moisturization by D-SQUAME® analysis and an investigator assessment on the Dry Skin Scale were performed on Days 1, 2, and 14. Additionally, subjects completed a self-assessment questionnaire on Day 1 and Day 14. Safety was assessed via spontaneous reporting and review of subject diaries. RESULTS: Clinical and statistically significant superiority to no treatment in terms of enhancing moisturization and desquamation per D-SQUAME® analysis at Day 2 and Day 14 (-2.51 and -3.07 from baseline, respectively; p<0.0001) was achieved. Treatment success as assessed by the investigator (via the Dry Skin Scale) and subject's self-assessment also indicated statistically significant improvements were achieved with the lactic acid/ceramide lotion (p<0.0001). No adverse events were reported during the study. CONCLUSION: The lactic acid/ceramide lotion provided a statistically significant and clinically meaningful improvement in moisturization and desquamation. CLINICALTRIALS.GOV IDENTIFIER: NCT04085809.
Keywords: D-SQUAME; Desquamation; ceramides; lactic acid; moisturization.
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