PurposeThese studies describe the testing of a novel, daily-use lip cream designed for individuals with lips prone to recurrent herpes labialis (RHL) that protects against environmental triggers.Subjects and methodsIn vitro occlusive and in vitro and in vivo photoprotection analyses, a characterization of normal vs dry lips, and a randomized, evaluator-blinded, clinical trial that assessed the lip cream in healthy subjects with dry lips were conducted. In the clinical trial, subjects applied the lip cream or were untreated and evaluated using transepidermal water loss (TEWL), corneometry, visual assessments of lip dryness, expert photographic evaluations, and subject-rated outcomes.ResultsThe lip cream’s in vitro water vapor transmission rate (84.1 g/(m2 h)) indicated moderate occlusivity. The lip cream, but not placebo or control (water), reduced ultraviolet A (UVA)- and UVB-induced DNA damage, and tumor necrosis factor-α (EpiDermFT) and pros-taglandin E2 release (EpiDermFT and EpiGingival™). The lip cream’s in vivo sun protection factor (SPF) was 12.2 (lower confidence limit, 11.3) and SPF/UVA protection factor ratio was 0.9. The characterization of dry vs normal lips identified differences in moisturization. In the clinical trial, the lip cream significantly decreased TEWL (difference: −7.19 [95% CI: −11.41, −2.98]; P<0.01), increased corneometry (difference: 4.62 [95% CI: 1.05, 8.19]; P<0.05), and reduced visual dryness (difference: −1.48 [95% CI: 2.24, −0.71]; P<0.001) compared to untreated subjects. Significant benefits were also observed on expert photographic assessments of scaling (difference: −0.89 [95% CI: −1.75, −0.03]; P< 0.05), cupping (difference: −1.50 [95% CI: −2.30, −0.70]; P<0.001), and healthy appearance (difference: −1.44 [95% CI: −2.29, −0.58]; P<0.01); differences in overall healthy appearance were not significant (P=0.51). Subject-rated assessments indicated improvements in cracking, dryness, and flaking in the lip cream group but worsening in untreated subjects.ConclusionThese studies indicate that this novel, daily-use lip cream protects against UV radiation, drying, and chapping, which are established environmental RHL triggers.

Background Facial chemical exfoliation (peeling) involves using a chemical agent to insult the skin and damage the cutaneous barrier, to reduce the signs of aging. The use of a moisturizer is advised postprocedure to promote repair of the epidermis. Biomimic moisturizer formulations may be effective treatment options for repair following facial peeling. Aims The aim of this study was to assess the local tolerance and cosmetic efficacy of three topical moisturizers (Physiogel® moisturizing creams), used after a 70% glycolic acid facial peel. Methods Three randomized, evaluator‐blind, parallel group studies were performed. Subjects were healthy females aged 30‐60 years with moderate to advanced photoaged skin (Glogau photoaging type II–III). All included a screening visit, a 7‐day washout period, a 70% glycolic acid facial peeling procedure, and randomization to a 14‐day treatment period with one of the three test products vs control. Results The primary endpoint was reached in all three studies; all completed subjects in the test groups received a favorable dermatologist global assessment score for tolerance at Day 14 (postchemical peel). Secondary assessments of local tolerance based on dermatologist and subject self‐assessment scores demonstrated improvements from baseline. No treatment‐related adverse events were reported in any study. Benefits for the test products were also observed in secondary efficacy analyses of transepidermal water loss and moisturization. Conclusions These studies have demonstrated the local tolerance and cosmetic efficacy of three moisturizing skin care products, when used for skin recovery after superficial chemical peeling on the face.

ObjectiveTwo studies were designed to evaluate the potential cosmetic benefit of a biomimetic, niacinamide‐containing moisturizing cream for the first time in humans.MethodsIn 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.ResultsIn 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, Ra, 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.ConclusionTwice 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.

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.