A Novel, Volumizing Cosmetic Formulation Significantly Improves the Appearance of Target Glabellar Lines, Nasolabial Folds, and Crow's Feet in a Double-Blind, Vehicle-Controlled Clinical Trial

January 2014 | Volume 13 | Issue 1 | Original Article | 41 | Copyright © 2014

Patricia K. Farris MD,a Brenda L. Edison BA,b Ronni L. Weinkauf PhD,b Barbara A. Green RPh MSb

aDepartment of Dermatology, Tulane University School of Medicine, New Orleans, LA
bNeoStrata Company, Inc., Princeton, NJ

Abstract

Facial lines and wrinkles are caused by many factors including constant exposure to external elements, such as UV rays, as well as the dynamic nature of facial expression. Many cosmetic products and procedures provide global improvement to aging skin, whereas injectable therapies are frequently utilized to diminish specific, target wrinkles. Despite their broad availability, some patients are unwilling to undergo injectables and would benefit from an effective topical option. A noninvasive option to volumize target wrinkle areas could also extend benefits of commonly used cosmetic anti-aging products. To this end, a two-step formulation containing the novel, cosmetic anti-aging ingredient, N-acetyl tyrosinamide, was developed for use on targeted wrinkle areas. The tolerability and efficacy of the serum plus cream were tested for 16 weeks in women with moderate facial photodamage on predetermined wrinkle areas (glabellar lines, nasolabial folds, under eye lines, and lateral canthal (crow's feet) wrinkles) in a single-center, randomized, double-blind, vehicle-controlled, clinical trial. Seventy women (47 Active group, 23 Vehicle group) completed the study. Digital photography, clinical grading, ultrasound and self-assessment scores confirmed improvement to wrinkle areas. The topical cosmetic formulation was statistically superior (P<0.05) to its vehicle in visually improving nasolabial folds, glabellar lines, crow’s feet, and under eye wrinkles and in reducing pinch recoil time. Both the test formulation and its vehicle were tolerated well. The novel, two-step cosmetic formulation reduced the appearance of wrinkles and increased skin elasticity thus providing an effective anti-aging option for target wrinkle areas. This study suggests that in addition to its use as monotherapy for reducing targeted lines and wrinkles this cosmetic formulation may be also serve as an adjuvant to injectable therapies.

J Drugs Dermatol. 2014;13(1):41-46.

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INTRODUCTION

Facial rhytides arise due to diminished production and increased breakdown of dermal matrix components, including collagen, glycosaminoglycans (GAGs), and elastin, as a result of natural aging and photodamage, coupled with repeated facial movement. Improvement of global photoaging symptoms can be achieved with effective, topical cosmetic formulations which typically address a wide range of skin concerns including dyspigmentation, laxity and surface lines. Physician intervention can provide significant, targeted improvement to wrinkle areas utilizing injectable treatments and a 3-dimensional approach of muscle relaxation, volume restoration and recontouring.1 However, despite their mainstream use in dermatology, injectable therapies may not be ideal for every patient seeking wrinkle reduction. For example, injectables are not completely without risks or discomfort and can be challenging to use on certain areas of the face. In addition, research has confirmed the existence of a needle-averse population and determined that less than 10% of the target population for botulinum toxin A (BoNTA) injections receives treatment.2 Furthermore, the nascent anti-aging patient may be apprehensive to adopt injectables as first-line, anti-wrinkle therapy. The availability of a noninvasive, clinically-proven, topical formulation that reduces the appearance of target lines and wrinkles may prove useful as a cosmetic treatment and potential alternative or adjunct to injectables for certain patients.

A two-step, volumizing formulation has been developed for application to target lines and wrinkles. The product contains a new cosmetic anti-aging ingredient, N-acetyl tyrosinamide, which increases matrix volume to plump and reduce the appearance of facial lines. An objective clinical study was conducted to evaluate the safety and effectiveness of this system in reducing the appearance of target wrinkle areas including glabellar lines, nasolabial folds, lateral canthal (crow’s feet) wrinkles and under eye lines and wrinkles.

Formulation Strategy Incorporating a Novel Volumizing Ingredient

The study products were developed to maximize the benefits of the amino acid compound, N-acetyl tyrosinamide. Independent research of this compound by dermatologist, Eugene J. Van Scott, MD and dermatopharmacologist, Ruey J. Yu PhD OMD was conducted under occlusion to exaggerate penetration and demonstrated a rapid increase in forearm skin thickness.3 Later, this compound was evaluated in several in vitro and in vivo models

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