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

Abstract

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 (Simpleâ 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 â Gel Cream (containing 4% niacinamide) as a moisturizer and Neutrogena Visibly Clear â 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]: À1.80 [À3.41, À0.19], 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.