Abstract

Background: Chronic inflammation damages barrier structure and skin homeostasis. Over 50% of the population reports self-declared sensitive skin. Heparan sulfate is a naturally occurring glycosaminoglycan, which has essential roles in skin functions. Here, we present the results of an open-label, single center clinical study testing a regimen created by Senté, Inc, which uses a patented low molecular weight heparan sulfate known as heparin sulfate analog (HSA). Methods: 46 subjects, Fitzpatrick skin types I-VI, were included in the intent-to-treat population. Subjects used HSA and Cleanser twice per day (AM/PM) and Sunscreen SPF 52 Tinted or SPF 49 Untinted at least once per day (AM). Clinical evaluations were conducted at visit 1 (baseline), visit 2 (week 2), and visit 3 (week 4). Subjects participated in the following procedures at each time point: Clinical Grading of Efficacy Parameters (4),Tolerability Evaluations, Mexameter Measurements, VISIA-CR Imaging, and Self-Assessment Questionnaires. Additionally, at baseline and week 4, skin swabs were collected from a subset of subjects to analyze the inflammatory markers IL-1α, IL-1RA, and PGE2. Results/conclusion: Overall results indicate that the regimen was effective showing a statistically significant improvement in facial redness. Likewise, there was a decrease in inflammation as indicated by a statistically significant downregulation in the aforementioned inflammatory markers. The facial products were well tolerated and well perceived by the subjects. This regimen addresses the unmet needs of those suffering from irritated and sensitive skin supported by clinical and scientific evidence.

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