A High-Potency, Multimechanism Skin Care Regimen Provides SignificantAntiaging Effects: Results From a Double-Blind, Vehicle-Controlled Clinical Trial
December 2012 | Volume 11 | Issue 12 | Original Article | 1447 | Copyright © December 2012
Patricia K. Farris MD, Brenda L. Edison BA, Irina Brouda MA, Ronni L. Weinkauf PhD, andBarbara A. Green RPh MSPatricia K. Farris MD,a Brenda L. Edison BA,b Irina Brouda MA,b Ronni L. Weinkauf PhD,b and Barbara A. Green RPh MSb
aDepartment of Dermatology, Tulane University School of Medicine, New Orleans, LA bNeoStrata Company, Inc, Princeton, NJ
Abstract
Skin aging is a multifaceted biological process characterized by the appearance of wrinkles, pigmentation irregularities, and loss
of firmness. These symptoms cannot be fully addressed by any single skin care ingredient or noninvasive cosmetic procedure. A
comprehensive treatment approach, including the use of clinically proven topical skin care formulations, provides optimal antiaging
effects. A high-strength skin care regimen (NeoStrata Skin Active; NeoStrata Company, Inc, Princeton, NJ) was developed to deliver
a combination of more than 35% active bene!t ingredients, including the a-hydroxy acid glycolic acid, the polyhydroxy acid gluconolactone,
maltobionic acid, N-acetylglucosamine, retinol, peptides, antioxidants, and apple stem cell extract. The products (cleanser,
day cream, night cream, eye cream) were formulated to provide antiaging bene!ts across all skin layers via multiple mechanisms
of action. The regimen was evaluated in a randomized, double-blind, vehicle-controlled clinical trial over 16 weeks, with a subset
continuing to 30 weeks. Sixty-nine Caucasian women (active group, n=44; vehicle group, n=25) completed 16 weeks of twice-daily
treatment. Results showed the active group improved significantly better than the vehicle group for: all clinician-graded aging symptoms
beginning as early as 2 weeks; pinch recoil as a measure of firmness/elasticity; dermal density, which was measured using
ultrasound; and total skin thickness, which was measured using digital calipers. Clinical photography revealed younger-looking skin.
Seventeen subjects from the active group continued to receive the active regimen until week 30. Improvement in all parameters of
aging was shown to be significantly greater at week 30 than at week 16, and dermal density continued to increase. The comprehensive
benefits observed in this study over the cosmetic vehicles are believed to have been achieved through the synergistic actions
of the benefit ingredients in the active regimen.
J Drugs Dermatol 2012;11(12):1447-1454.
INTRODUCTION
Aged skin is characterized by the appearance of wrinkles,
pigmentation irregularities, and loss of firmness
due to diminished functionality of skin cells from both
intrinsic and extrinsic factors, of which exposure to ultraviolet
(UV) light and free radicals have the largest negative impact.1 These extrinsic factors notably cause a reduction in the
production of collagen and extrafibrillar matrix components,
leading to wrinkles, loss of firmness, and abnormal pigment
production, causing age spots and other pigmentation irregularities.
Skin aging, a multifaceted biological process with
multiple symptoms, cannot be fully addressed by any single
skin care ingredient or noninvasive cosmetic procedure.2
Therefore, a comprehensive treatment approach, including
the use of clinically proven topical skin care formulations,
provides optimal antiaging effects. Well-formulated antiaging
products can address many signs of skin aging when used
as monotherapy3,4 and can enhance and extend the effects of
cosmetic procedures when used in combination.5
A high-strength skin care regimen that delivers a combination
of more than 35% active benefit ingredients, including
α-hydroxy and polyhydroxy acids, maltobionic acid (MBA), Nacetylglucosamine
(NAG), retinol, peptides, antioxidants, and
apple stem cell extract, was developed to provide antiaging
benefits across all skin layers via multiple mechanisms of action.
The regimen consists of a facial cleanser, a day cream
with sunscreen, a night cream, and an eye cream. The tolerability
and effectiveness of this regimen were evaluated in a
randomized, double-blind, vehicle-controlled clinical trial.
Comprehensive antiaging therapy addresses both prevention and
reduction of various physiologic mechanisms and visual signs associated
with aging of the skin. To this end, the benefit ingredients
in the test regimen were chosen to target multiple mechanisms
of action in skin (Table 1). Preventive agents, including broadspectrum
sunscreens and antioxidants such as Chardonnay grape
seed extract, were selected to reduce exposure to and damage
