Pilot, Multicenter, Open-Label Evaluation of Safety, Tolerability and Efficacy of a Novel, Topical Multipotent Growth Factor Formulation for the Periorbital Region
December 2015 | Volume 14 | Issue 12 | Original Article | 1410 | Copyright © December 2015
Hema Sundaram MD,a Michael Gold MD,b Heidi Waldorf MD,c Mary Lupo MD,d Vivien L. Nguyen PharmD,e and Jwala Karnik MDe
aSundaram Dermatology, Cosmetic & Laser Surgery, Rockville, MD
bTennessee Clinical Research Center, Nashville, TN
cMount Sinai Dermatology Associates, New York, NY
dLupo Center for Aesthetic and General Dermatology, New Orleans, LA
eSuneva Medical, Inc., Santa Barbara, CA
Abstract
BACKGROUND: This multicenter, open-label pilot study evaluated safety, efficacy and tolerability of a topical formulation containing a multipotent growth factor resignaling complex (MRCx), when applied to infraorbital and lateral canthal skin.
METHODS: Thirty-nine female subjects with mean age of 56.8 years who had periorbital lines and wrinkles, uneven skin texture, puffiness, and lack of skin firmness were enrolled, and 38 completed the study. All subjects applied the multipotent growth factor formulation bilaterally to the periorbital area, twice daily for 60 days. Efficacy and treatment-related adverse events were evaluated at Baseline and days 14, 30, and 60. Investigators rated the periorbital areas based on 10-point scales.
RESULTS: Subjects’ self-reported compliance with treatment was greater than 99% throughout the study. At day 60, all subjects had improvement in infraorbital brightness (≥ 2 points), moistness (≥ 2 points), wrinkles (≥ 1 point), sallowness (≥ 1 point), crepiness (≥ 1 point), smooth texture (≥ 1 point), skin tightness (≥ 1 point), and skin tone (≥ 1 point). Investigator-rated assessments showed ≥ 1-point improvement for lateral canthal wrinkles, dyschromia/mottled pigmentation, skin tone, overall brightness, and moistness. Investigator-rated scoring on the Global Aesthetic Improvement Scale (GAIS) demonstrated that 67.6% of subjects were much improved/improved at day 14, and 63.1% remained improved at day 60. Overall, 76.2% and 79.0% of subjects were very pleased/pleased/mostly pleased with the appearance of their infraorbital and lateral canthal areas at day 60. Adverse events comprised one case of mild canthal erythema, and one case of mild eye irritation, both of which were respectively resolved.
CONCLUSIONS: This pilot study demonstrated that the topical multipotent growth factor formulation was safe, effective and well tolerated for periorbital skin rejuvenation.
J Drugs Dermatol. 2015;14(12):1410-1417.
INTRODUCTION
The periorbital area is typically one of the first facial areas to manifest signs of aging.1,2 There is consequently a high patient demand for periorbital rejuvenation.1-4 Due to patient preference for less invasive treatments, many nonsurgical procedures have been developed.3-14 Topically-applied formulations have the potential to serve as synergistic adjuncts before or contemporaneously with in-office procedures such as botulinum toxin type A, soft tissue filler injections, and laser or light energy device procedures. They can also be used post-procedurally to maintain results, and are of value to patients who wish to be treated at home rather than in a physician's office.
Recent research has shown that growth factors derived from fibroblasts, keratinocytes, platelets, lymphocytes, and mast cells have significant potential to correct visible skin damage.15-17 Epidermal and fibroblast growth factors play important roles in the regeneration and proliferation of skin cells, including increasing the accumulation of collagen type 1 alpha 1 protein in skin tissue.16 These growth factors are also responsible for the inhibition of UV-induced skin damage.16 Platelet-derived growth factor, epidermal growth factor, transforming growth factor and several other growth factors and cytokines have been demonstrated to increase in vivo production of type I collagen and hyaluronan.17
Fibroblast growth factors are part of a large family of polypeptides essential for embryonic development and a variety of diverse biological functions.18,19 They are essential for maintaining skin homeostasis and tissue repair.18 Fibroblast function diminishes as the skin ages, resulting in reduced synthesis of collagen types I and III.19 Exposure to environmental extrinsic factors, such as ultraviolet light and cigarette smoke, further
