Zoe Diana Draelos1,2, Steven Hall1,2, Carey Munsick1,2. 1. Dr. Draelos is with Dermatology Consulting Services, PLLC, in High Point, North Carolina. 2. Dr. Hall and Ms. Munsick are with Sandoz Inc., in Princeton, New Jersey.
Abstract
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.
RCT Entities:
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.