Cosmetic benefits of a novel biomimetic lamellar formulation containing niacinamide in healthy females with oily, blemish‐prone skin in a randomized proof‐of‐concept study

Objective A randomized study was designed to evaluate the potential cosmetic benefit of a biomimetic, niacinamide‐containing moisturizing cream in oily, blemish‐prone skin. Methods Healthy adult women with oily, blemish‐prone skin were randomized to one of three treatment groups: test, control, or positive control. In the test group, subjects used the test product (containing 4% niacinamide), plus the standard cleanser (Simple® Kind to Skin Moisturizing Facial Wash). In the control group, subjects received no moisturizer but used the standard cleanser. In the positive control group, subjects used Vivatinell Acnecinamide ® Gel Cream (containing 4% niacinamide) as a moisturizer and Neutrogena Visibly Clear ® Spot Clearing Facial Wash (containing 2% salicylic acid) as a cleanser. The positive control regimen was included to provide a comparison for estimates of effect size. The primary objective was to evaluate skin moisturization as a change from baseline in corneometer values at 8 h for the test regimen vs. the control regimen. Analysis of covariance was applied for the primary efficacy analysis. Results A total of 132 subjects were randomized with 44 included in each treatment group. A significant difference was observed in the primary endpoint for the test regimen compared with the control regimen (least‐squares mean difference [95% CI]: 3.12 [0.68, 5.56], P  = 0.0128). A trend was observed in favour of the positive control regimen compared with the control regimen. Secondary measurements of moisturization supported the primary efficacy outcome. Assessment of blemishes showed a significant difference between the test regimen vs. the control regimen for change from baseline in mean total blemish count at Week 8 (least‐squares mean difference [95% CI]: −1.80 [−3.41, −0.19], P  = 0.0290). No statistical comparisons between the positive control group and the test group were performed. Conclusion This study provides proof‐of‐concept evidence that a novel lamellar lipid moisturizer containing niacinamide, in combination with a standard cleanser, can help moisturize the skin and provide an overall improvement in the complexion appearance of people with blemish‐prone skin. Study registration: NCT03093181.