2025-10-29 10:09:17
Presenters: Lain E, Waibel J, Boyd C
Background: Dry skin affects a substantial portion of the global population, with millions experiencing discomfort and compromised skin function daily. Environmental factors, age, genetics, and lifestyle habits all contributed to its prevalence. With aging, the demand for effective moisturizing products increases due to natural declines in skin barrier integrity and hydration. Despite the availability of numerous skincare products, managing dry skin remains a persistent challenge, underscoring the need for well-substantiated therapeutic approaches. Hyaluronic acid (HA) has been recognized as a potent humectant with the ability to attract and retain moisture, thereby promoting skin elasticity and barrier function. Urodele collagen extract, a proprietary, patented ingredient, has demonstrated the capacity to enhance dermal extracellular matrix (ECM) deposition, including HA, collagen, and elastin. Additionally, the extract showed promise in reducing fine lines and improving structural skin integrity.
Objective: This prospective, open-label, multi-center clinical study investigated the efficacy and tolerability of REGENX HYDRATE SERUM in female subjects aged 30–55 years and Fitzpatrick Skin Types ranging between 1 and 6, presenting with moderate photodamage and moderate to severe facial dryness.
Methods: Twenty-six subjects completed the study across three U.S. sites: Miami, Florida; Birmingham, Michigan; and Austin, Texas. After meeting inclusion and exclusion criteria, subjects discontinued their regular skincare regimens and used sponsor-provided cleanser, broad-spectrum SPF, and REGENX HYDRATE SERUM for 12 weeks. The serum was applied twice daily to the full face. The primary objective was to assess the product’s ability to deliver immediate (15-minute) and sustained moisturization, with secondary objectives evaluating improvements in skin brightness, hydration, and the appearance of fine lines and wrinkles. Baseline assessments included the Expert Grader Dryness Skin Scale, Tactile Roughness Scale (grades 2–3), GLOGAU classification, and Fitzpatrick skin typing. Standardized digital photography and Canfield Gen 5 VISIA CRP imaging were conducted at baseline, week 4, week 8 and week 12. Moisturization was quantitatively assessed with corneometer at baseline, 15 minutes postapplication, and at weeks 4, 8, and 12. Subjects returned for in-person evaluations at days 30, 60, and 90, during which expert visual grading, clinical photography, subject self-assessment questionnaires, and adverse event monitoring were completed. To complement clinical outcomes, one subject was randomly selected to undergo preauricular 2-mm punch biopsies at baseline and week 12.
Results: Corneometric analysis demonstrated a greater than 100% increase in skin hydration within 15 minutes (from initial 0.19 to 0.44 after 15 minutes) of REGENX HYDRATE SERUM application, based on normalized data from two clinical sites involving 14 participants. This elevated hydration level was sustained throughout the 12-week study period (from initial 0.19 to final 0.45). Expert grading further indicated substantial clinical improvement in skin condition. Dryness scores, rated on a 0–4 scale (0 = no dryness; 4 = extreme xerosis with inflammation, large scales, and cracks), decreased from a mean of 2.15 (moderate xerosis) to 0.26 (near normal). Tactile roughness, assessed on a 0–4 scale (0 = none; 4 = extreme), improved from a mean of 2.10 (moderate) to 0.43 (minimal). Histological evaluation of preauricular biopsies from a subset of participants also suggested a reduction in inflammatory markers, supporting the serum’s role in enhancing epidermal barrier function and mitigating inflammation in dry, photodamaged skin.
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