Anti-Aging Proof of Concept Study: Results and Summary

September 2014 | Volume 13 | Issue 9 | Original Article | 1074 | Copyright © 2014

Suzanne Bruce MD,a Jwala Karnik MD,b Laurence Dryer PhD,c and David Burkholder PhDd

aThe Center for Skin Research, Suzanne Bruce and Associates, Houston, TX
bSuneva Medical, Inc., Santa Barbara, CA
cValeant Pharmaceuticals, Long Beach, CA
dPD Pharmaceutical Consulting, Guilford, CT

Abstract

BACKGROUND AND OBJECTIVES: The etiology of aging human skin includes intrinsic physiologic changes greatly accelerated by photoaging, predominantly through exposure to UV light. Consumer interest and demand for anti-aging skin care products is extremely high especially in light of aging populations. Prenatal (fetal) tissue has been shown to possess healing characteristics and regenerative effects. A proprietary tissue engineering technology has been developed to produce a soluble human extracellular matrix material with growth factors and proteins. Neonatal cells are cultured on microbeads under conditions of low oxygen tension. This human cell-conditioned media (hCCM) contains a variety of growth factors and cytokines similar to those found in fetal cells and has been incorporated into a topical preparation for use in facial wound healing (after laser resurfacing procedures) and improving the appearance of aging skin. The objective of this study was to observe the effects of an MRCxTM-containing topical skincare regimen on subjects with demonstrated aging skin damage (photodamage) when used consistently over a 3 month time period.
METHODS: Female subjects age 35-65 with Fitzpatrick Skin Type I-IV and mild to moderate amounts of photodamage, fine lines, and wrinkles used Regenica® Replenishing Crème and Regenica® Renew SPF 15 for 3 months. At each visit, photos were taken of subjects while investigators completed skin grading assessments and subjects completed self-assessments. Investigator assessments included evaluation of tactile roughness, visual texture, wrinkles, blotchiness, skin tone evenness, radiance, and translucence on a 5-point scale. Subjects’ self-assessments included assessment of fine lines and wrinkles, firmness, evenness of skin tone, brightness, resilience, clarity, and radiance. Changes from baseline were evaluated for each parameter and P values for changes from baseline to each study visit for investigator’s assessments and to end-of-study for self-assessments were calculated.
RESULTS: Eighteen of 21 enrolled female subjects completed the study. Three subjects chose to drop from the study. Statistically significant improvements in investigator assessments of tactile roughness, visual texture, wrinkles, blotchiness, skin tone evenness, radiance and translucency compared to baseline were observed at weeks 4, 8, and 12 after initiating treatments. Progressive improvement was seen through the last study visit (visit 5, week 12). Similar statistically significant improvements in subjects’ self-assessments were seen comparing the first post-baseline visit (visit 2, week 2) to subsequent visits. 93.5 % subjects agreed (somewhat or strongly) with all of the positive subject assessment statements at week 12. Importantly, 100 % of subjects indicated at the end of the study that they would recommend the product to a friend and would want to purchase the product. No treatment-related adverse events were recorded during the study.
CONCLUSIONS: Regenica was safe and clinically effective in reducing anti-aging effects in this group of female subjects aged 35-65 years as measured by both investigator assessments and subjects’ self-assessments.

J Drugs Dermatol. 2014;13(9):1074-1081.

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introduction

The function and appearance of human skin degenerates as part of the intrinsic (chronological) aging process. The effects of environmental factors (sun, heat, pollution, smoking) and most importantly, solar ultraviolet light (UV) contribute to the superimposed photoaging process.1,2 Aging and photodamaged skin are characterized by fine and course wrinkles, dyspigmentation, sallow color, dry texture, and lossoftone.1,3 Consumer interest and demand for anti-aging treatments including medical, surgical, and cosmetic approaches is extremely high, in part because of the aging population.2,4

Prenatal (fetal) tissue has been shown to possess healing characteristics and regenerative effects.5 A proprietary tissue engineering technology has been developed to mimic conditions of the embryonic environment that triggers neonatal cells to produce a soluble human extracellular matrix material along with a variety of growth factors and cytokines.6 Neonatal cells are grown on microbeads under conditions of low oxygen tension. They subsequently produce growth factors and cytokines in types and quantities similar to those of fetal cells. The resulting media is known as human cell-condi

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