OBJECTIVE: To demonstrate the in vitro activities of panthenol, palmitoylethanolamide (PEA), and niacinamide (NAM) and determine the biophysical properties, clinical safety, tolerability together with efficacy of two developmental anti-redness (AR) formulations containing these ingredients, in alleviating facial redness associated with winter xerosis in healthy volunteers with sensitive skin. METHODS: The anti-inflammatory and skin protective properties of panthenol, PEA and NAM were evaluated in vitro. The physical properties of the AR formulations were analysed using measurement of water vapour transport rate (WVTR) and infrared spectroscopy. Clinical studies were performed between the months of December and April (2014-2015) with efficacy assessed during the winter. Facial redness, irritation, sensitization potential, photo-irritation, and photo-sensitization were evaluated. Self-assessed adverse reactions were reported in diaries of use. RESULTS: Panthenol and PEA reduced prostaglandin E 2 , interleukin-6, and thymic stromal lymphopoietin levels in vitro, while NAM induced nicotinamide adenine dinucleotide (NAD) levels and the keratinocyte differentiation markers: filaggrin (2-fold increase, P < 0.001), loricrin (2-fold increase, P < 0.05), involucrin (2 fold increase, P < 0.001) & peroxisomal proliferator activated receptoralpha (1.5 fold increase, P < 0.05). The two AR products exhibited low WVTR vs. no treatment (P < 0.001) and displayed an ordered lipid structure. The day cream formulation protected against ultraviolet B radiation in vitro. A total of 382 participants were included in clinical studies which showed the AR formulations significantly improved facial redness associated with winter xerosis (Day 29 mean change from baseline: AR day cream 0.77 (P < 0.001); AR serum 0.67 (P < 0.001)). No irritation, sensitization, photo-irritation, photo-sensitization or product-related adverse reactions were observed or reported in the clinical studies. CONCLUSION: The new products significantly improved skin redness associated with winter xerosis in participants with selfperceived sensitive skin. Both products were well tolerated with a suitable safety profile for topical use in subjects with sensitive skin. Evaluationof anti-redness face cream and serum S. J. Nisbet et al. 536 Evaluation of anti-redness face cream and serum S. J. Nisbet et al. 538 Evaluation of anti-redness face cream and serum S. J. Nisbet et al. Evaluation of anti-redness face cream and serum S. J. Nisbet et al. 540 Evaluation of anti-redness face cream and serum S. J. Nisbet et al. 542 Evaluation of anti-redness face cream and serum S. J. Nisbet et al. Evaluation of anti-redness face cream and serum S. J. Nisbet et al. P value <0.001 <0.001 CI, confidence interval; ITT, intention-to-treat; SD, standard deviation. 544Evaluation of anti-redness face cream and serum S. J. Nisbet et al.

A randomised clinical trial to assess control of oral malodour by a novel dentifrice containing 0.1%w⁄w o-cymen-5-ol, 0.6%w⁄w zinc chloride Objectives: To assess the ability of a 0.1% w ⁄ w o-cymen-5-ol ⁄ 0.6% w ⁄ w zinc chloride ⁄ sodium fluoride dentifrice to control oral malodour compared to a sodium fluoride control dentifrice. Design: Following baseline measurement of oral volatile sulfur compounds (VSCs), the subjects brushed twice daily for 1 week with either the test or control dentifrice. The VSC concentration in breath samples was monitored up to 12 hours post-treatment, by gas chromatography (GC). Results: 75 subjects were included in the efficacy analysis. Relative to the sodium fluoride control dentifrice group the o-cymen-5-ol ⁄ zinc chloride ⁄ sodium fluoride dentifrice exhibited statistically significant reductions (P < 0.0001) in hydrogen sulfide, methyl mercaptan and total measured VSCs immediately and after 1, 2, 3 and 12 (overnight) hours posttreatment. Conclusion: The results of the present clinical study demonstrated that the use of the 0.1% w ⁄ w o-cymen-5-ol ⁄ 0.6% w ⁄ w zinc chloride ⁄ sodium fluoride dentifrice over a one week period provided a statistically significant benefit in controlling oral malodour for up to 12 hours post-treatment compared to a sodium fluoride control dentifrice.

PurposeThis 3-week, open-label, noncomparative clinical study evaluated the skin acceptability of a cosmetic moisturizer in subjects with sensitive skin, by monitoring adverse events (AEs) and cutaneous discomfort related to normal usage.Materials and methodsFemale subjects aged between 18–60 years, with Fitzpatrick phototype classification I–IV and sensitive skin, verified by a positive reaction on the stinging test at screening, were included. Subjects applied the moisturizer to their face and body twice daily for 21±2 days at home and recorded study product usage and feelings of cutaneous discomfort (eg, dryness, prickling, stinging, and itching) in a diary; any AEs were reported to the clinic. At study end, skin acceptability of the moisturizer was investigator-assessed based on the nature of AEs and subjects’ self-reported feelings of discomfort, and by clinical evaluation of skin reactions in the area of moisturizer application (appearance of erythema, formation of edema, and skin desquamation; scored according to an adapted Draize and Kligman scale). Only subjects with a treatment compliance of ≥80% were included in the final analysis.ResultsIn total, 35 subjects initiated and completed the study; all were compliant to the minimum study product usage. Per investigator clinical dermatological assessment at study end, none of the 35 subjects had skin reactions in the area of moisturizer application and there were no reported AEs. One subject reported sensations of mild prickling and itching immediately after applying the moisturizer (not classified as AEs), which spontaneously remitted after complete absorption of the product and were noted only in exposed areas. These events were considered by the investigator as being possibly/probably related to the use of study product; however, no clinical signs of skin reaction were observed in the exposed areas.ConclusionThis cosmetic moisturizer appears generally well tolerated and suitable for topical use in subjects with sensitive skin.

Background Some moisturizing formulations can help restore and maintain the barrier function of the skin. Objectives This study was designed to assess the hydration potential of three lamellar moisturizers relative to a control (nonlamellar) moisturizer. Methods Healthy adults aged 18 to 65 years with self‐reported sensitive skin, dry or very dry skin and Corneometry values of ≤40 a.u. on the lower legs, entered this randomized, evaluator‐blind study. Products A and B together with a control product (Control X) were applied to one leg, while Product C and Control Y were applied to the other leg; with an untreated control site in both cases. The primary efficacy variable was the change from baseline in Corneometer assessments at 24 hours (Products A and B) or 12 hours (Product C) postapplication. Results At all timepoints (n = 30), Products A and B showed higher mean Corneometer readings compared to baseline and changes from baseline were statistically significant when compared to untreated sites. Higher mean readings relative to baseline were seen at sites treated with Control X (smaller magnitude than Product A and B) and with Product C. These changes were significant compared to the untreated site at 30 minutes and 2 hours (Control X), and at 30 minutes and 12 hours (Product C). Additionally, Control Y increased significantly at 12 hours. Conclusion A single application of a lamellar moisturizer significantly increased hydration of the stratum corneum for up to 24 hours (Products A and B) or 12 hours (Product C).

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.

These findings suggest that the lamellar moisturizer has low irritant and allergenic potential.