Improved Texture and Appearance of Human Facial Skin After Daily Topical Application of Barley Produced, Synthetic, Human-like Epidermal Growth Factor (EGF) Serum

May 2012 | Volume 11 | Issue 5 | Original Article | 613 | Copyright © 2012

Abstract

A three month, open-label, single center study was conducted to determine whether a uniquely derived serum containing barley bioengineered, human-like epidermal growth factor protein could improve visible signs of photodamage and aging in facial skin. Twenty-nine females, aged 39 to 75 years, with mild to severe, fine and course rhytids, photodamage, and pigmentation were enrolled. Subjects then applied the treatment serum per the prescribed protocol twice-daily for 3 months, in addition to the use of a basic sunscreen and facial cleanser. In-person clinical evaluations and subject self-assessment questionnaires were administered at each follow up visit. In addition, clinical photography was completed at baseline, and each subsequent visit. Clinical evaluations showed statistically significant improvement in the appearance of fine lines and rhytids, skin texture, pore size, and various dyschromatic conditions apparent within the first month of use, and continuing improvement trends for the duration of the study. The treatment serum was well tolerated with minimal treatment-related complications reported throughout. Efficacy of this novel serum and treatment protocol resulted in meaningful improvements in photodamage and visible signs of aging.

J Drugs Dermatol. 2012;11(5):613-620.

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INTRODUCTION

Present in a wide variety of tissues and fluids, epidermal growth factor protein (EGF) acts on a subset of the tyrosine kinase receptor family.1 Epidermal growth factor serves primarily in a mitogenic and mobilizing capacity on keratinocytes, fibroblasts, and smooth muscle cells. These findings have led to its successful use in improving healing times in corneal abrasions, radiation-induced mucositis, and diabetic ulcers.2-9 As humans naturally age, EGF receptors (EGFRs) and EGFR response appears to decrease.10,11 In addition to decreased EGFR activity, the epidermis thins and cosmetically significant signs of photodamage (wrinkles, dyschromia, and rough, loose skin) evolve over time as a result of decreased and abnormal dermal collagen and elastin and deregulated melanocyte activity. 12,13 As topical EGF in other applications and studies has been well tolerated,14 we thus performed an open label clinical trial investigating the efficacy of a topically applied novel serum containing human-like EGF protein bioengineered from barley on the appearance and texture of skin in volunteers.

METHODS AND MATERIALS

This study employed a long-form subject-consent of the format commonly utilized by the Western Institutional Review Board, which conforms to the ethical guidelines of the 1975 Declaration of Helsinki. In addition, Standard Operating Procedures for Clinical Research in accordance with the appropriate Moy-Fincher-Chipps oversight committee, and Good Clinical Practice was observed. All subjects were regularly evaluated for changes in presentation of facial skin concurrent with a regimen of twice-daily topical application of EGF serum (BIOEFFECT EGF Serum, Figures 1 and 2).25

Subjects were also given a proprietary botanical facial cleanser, Renewal Foaming Cleanser,23 and SPF 30 sunscreen, DNA Defense SPF 30+.24 These products constituted “The Regimen,” which was followed for a compulsory 3-month period, with an optional 3-month extension totaling 6 months as tolerable by the subject. During the course of the study, Tretinoin, retinol and other Vitamin A derivatives, additional exfoliants, and corticosteroids were not used by any active subject.

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