Cosmetic benefit of a biomimetic lamellar cream formulation on barrier function or the appearance of fine lines and wrinkles in randomized proof-of-concept clinical studies

摘要

Objective Two studies were designed to evaluate the potential cosmetic benefit of a biomimetic, niacinamide-containing moisturizing cream for the first time in humans. Methods In both studies, healthy women were randomized to use two treatments, one for the left side of the body and one for the right, from three options: the test cream, a positive control or no treatment (use of standard cleanser only). Treatments were applied twice daily for 4 weeks to the face and forearms (Study 1) or the face only (Study 2). Instrumental and clinical skin assessments were performed by trained technicians. Study 1 involved tape stripping and a 5-day no-treatment ('regression') period at the end of the 4 weeks. Independent lay graders were asked to grade the skin texture of subjects in Study 2 from high-resolution photographs. Results In Study 1 (n = 66), the test cream significantly decreased the transepidermal water loss (TEWL) values on the forearm, and in the cheek area of the face, relative to baseline and compared to no treatment, and increased skin Corneometer values. The improvements were partially retained during a subsequent 5-day period of no treatment. Increases in TEWL values on skin subjected to tape stripping were significantly lower after 4 weeks of using the test cream compared to no treatment. In Study 2 (n = 72 subjects with visible signs of ageing), there was a favourable trend in the change from baseline of a skin roughness parameter, R-a, for the test cream compared to no treatment. There were statistically significant improvements in the Fitzpatrick wrinkle score compared to no treatment, decreases in TEWL and increased Corneometer values and Cutometer values (R5 elasticity parameter). Grading of high-resolution images failed to detect the improvements in skin texture (defined as pores, smoothness and unevenness) for the test cream vs. no treatment. No treatment-related serious or severe adverse events were reported. Conclusion Twice daily application of the test cream over 4 weeks had beneficial effects on skin barrier function, moisturization, wrinkle dimensions and elasticity compared to no treatment. These studies provide proof-of-concept evidence and highlight the cosmetic benefit of the biomimetic lamellar cream formulation. Study registration: NCT03216265, NCT03180645.