A novel, topical multipotent growth factor was found to be safe, effective, and well tolerated for periorbital skin rejuvenation, according to results from an open-label pilot study.
The product, manufactured by Suneva Medical and known as Regenica Revitalizing Eye Creme, contains a novel multipotent resignaling complex (MRCx), in which human fibroblasts are harvested from a neonatal cell bank and cultured in bovine-free media. “The cultured cells are then anchored to dextran microbeads and suspended in a culture chamber within which the oxygen tension is decreased from 21%” to less than 5%, researchers led by Dr. Hema Sundaram explained in the December 2015 issue of the Journal of Drugs in Dermatology (2015;14[12]:1410-17). “During this process, the cells revert to an embryonic-like state exhibiting stem cell properties, releasing multipotent growth factors including significant quantities of vascular endothelial growth factor (VEGF), keratinocyte growth factor (KGF), and interleukin-8 (IL-8).”
Dr. Sundaram, a dermatologist who practices in Rockville, Md., and her associates at three other centers in the United States enrolled 39 women who had periorbital lines and wrinkles, uneven skin texture, puffiness, and a lack of skin firmness. The women were instructed to apply the formulation to the periorbital area twice a day for 60 days and the researchers evaluated efficacy and treatment-related adverse events at baseline, day 14, day 30, and day 60. The women completed a questionnaire that assessed their self-perception of treatment-related changes in the skin appearance at every visit. At the same time, investigators used 10-point scales to rate the periorbital areas and the Global Aesthetic Improvement Scale (GAIS) to assess the overall improvement on day 14, 30, and 60.
The mean age of the women was 57 years and 38 completed the study. The researchers reported that at day 60, all of the participants had improvements in infraorbital brightness, moistness, wrinkles, sallowness, crepiness, smooth texture, and skin tone. According to investigator-rated scoring on the GAIS, 68% of the women were “improved” or “much improved” at day 14 and 63% remained improved at day 60.
At day 60, 76% of women said they were “very pleased/pleased” (39.4%) or “mostly pleased” (36.8%) with the appearance of their infraorbital areas at day 60, while 79% indicated they were “very pleased/pleased” (44.8%) or “pleased” (34.2%) with the appearance of their lateral canthal areas. Adverse events were rare and consisted of one case of mild canthal erythema which lasted 2 days and one case of mild eye irritation which lasted 1 day.
The researchers acknowledged that the evidence level of the study findings “would be increased by larger, vehicle-controlled studies with blinded evaluation.”
The study was supported by research grants from Suneva Medical. Dr. Sundaram reported being a clinical investigator and/or consultant for numerous companies, including Suneva. Two of the study authors are Suneva employees and the rest reported having numerous ties to the pharmaceutical industry.