Clinical Evidence of Dermal and Epidermal Restructuring from a Biologically Active Growth Factor Serum for Skin Rejuvenation

March 2019 | Volume 18 | Issue 3 | Original Article | 290 | Copyright © March 2019


Frank Barone MD FACS,a Sameer Bashey MD FAAD,b and Frederick W. Woodin Jr. BSc

aEvolv Plastic Surgery and Medical Aesthetics, Toledo, OH bZO Skin Centre, Beverly Hills, CA cZO Skin Health, Inc., Irvine, CA

2D Image Analysis Average wrinkle severity, fine line counts, and total wrinkle counts showed statistically significant improvement at multiple time points (Table 2):Compared to baseline, average fine line count and wrinkle severity improved significantly at week 12: -17.66% and -10.32%, with 68.3% and 82.9% showing improvement, respectively (P less than 0.001 in both analyses). Investigators also noted improvements in
Average wrinkle severity, fine line counts, and total wrinkle counts showed statistically significant improvement at multiple time points (Table 2):Compared to baseline, average fine line count and wrinkle severity improved significantly at week 12: -17.66% and -10.32%, with 68.3% and 82.9% showing improvement, respectively (P less than 0.001 in both analyses). Investigators also noted improvements in
the week 12 deep line counts (-8.51%), and the average wrinkle length (-3.0%) and average wrinkle width (-0.08%), although these improvements did not reach statistical significance. Total wrinkle counts improved by 4.45% and 4.11% at weeks 2 and 8, respectively (P equals 0.014 and 0.035). Improvements in total wrinkle counts lost statistical significance at weeks 4 and 8, and emerging line counts worsened significantly throughout the study for possible reasons that will be addressed in the Discussion section. 3D Evaluations For the 15 patients who underwent 3D image analysis, mean week 12 improvements in maximum indentation depth were 13.22% and 11.92%, respectively (P less than 0.001 and P equals 0.024), with 93.3% and 73.3% showing improvement, respectively (Table 3). Results reached statistical significance in all parameters at all time points, except for week 8 in maximum depth. Subjective Participants’ perceptions of the study product and its effects were highly favorable. At week 12, 92.7% of patients said they saw the following (P<0.001 in all analyses):
3D Evaluations
Similarly, 87.8% of participants agreed at week 12 that their skin appeared and felt healthy, and also felt moisturized and hydrated, with visible improvement in dryness. Between 70.7% and 78% of subjects said their skin appeared and felt tighter, and also appeared more youthful, with visible improvement in density/plumpness (P less than 0.001 in all analyses).

DISCUSSION

To counter the signs and symptoms of facial skin aging, and to fortify skin against intrinsic and extrinsic harms, patients continue to seek safe, effective, and advanced skincare technologies. Not only did the growth factor serum studied herein achieve statistically significant improvements in most parameters assessed by experts and subjects, but these improvements generally began to appear at the earliest measurement opportunity. At week 2, investigators noted small (1.73%–3.90%) but statistically significant improvements in crow’s feet, firmness, tactile elasticity, visual texture, radiance, and overall appearance. By week 4, all but one of these variables, overall appearance, reached double-digit improvements. Also, at week 2, 55%–95% of participants perceived clinically significant improvements in overall skin characteristics such as moisturization, hydration, and appearance. Corneometer and cutometer measurements showed statistically significant gains over baseline starting at week 2, while the first ultrasound measurements of dermal thickness, performed at week 4, revealed statistical significance.In 3D analysis, the only finding that did not reach statistical significance was maximum depth at week 8 (4.72% mean improvement; P=0.179). With a 15-subject subpopulation, changes in one or two subjects may have skewed these findings. Perhaps more reliable are the indentation measurements, which gauge the smoothness of the ridge and valley, so to speak, of crow’s feet at maximum depth. These figures went from a 9.53% improvement at week 8 (P=0.007 versus baseline) to 13.22% at week 12 (P<0.001).In 2D analysis, wrinkle counts at weeks 2 and 8 and severity at all time points improved significantly, while wrinkle width and length showed no statistical improvement. It is possible that im