16470 Clinical efficacy of a novel growth factor–based serum: A randomized, double-blind, placebo-controlled, cross-over study

Abstract

Topical physiologically balanced growth factors have been shown to provide improvements in skin rejuvenation. Advancements in cell culture technology have enabled harvesting of a novel growth factor blend derived from neonatal human fibroblasts cultured under hypoxic conditions, leveraging unique properties exclusive to this particular environment. To assess the efficacy and tolerability of the novel growth factor–based serum (TNSA) on subjects presenting with moderate to severe facial photodamage, a 24-week, randomized, double-blind, vehicle placebo–controlled, cross-over study was conducted. 66 women aged 37-70 with Fitzpatrick skin types I-V completed the 24-week study (Active: n = 43, Control: n = 23). During phase 1 (baseline to week 12), TNSA (Active) and vehicle (Control) were applied to the face twice daily. Both groups also used a basic skincare regimen (cleanser and moisturizer with SPF). During phase 2 (week 12-24), Control crossed-over and received TNSA while Active continued with TNSA. TNSA provided significant improvements over Control in coarse lines/wrinkles at weeks 4, 8, and 12; overall photodamage, fine lines/wrinkles and overall hyperpigmentation at weeks 8 and 12; and sagging at week 12 (all P ≤ .01; Wilcoxon signed rank test). After Control cross-over to TNSA during phase 2, significant improvements in overall photodamage, sagging, coarse lines/wrinkles, and fine lines/wrinkles were achieved at weeks 18 and 24 compared with week 12 “baseline.” Results from the validated patient reported outcome tool Face-Q and histologic analysis of biopsies support improvements observed by the investigator. Study results suggest that the novel growth factor-based serum may provide a treatment option for patients seeking facial skin rejuvenation.