Efficacy and Tolerability of Stable Hybrid Cooperative Complexes of High- and Low-Molecular Weight Hyaluronic Acid in Asian Patients: An Open-Label Study.

Background: Few studies of Profhilo for facial skin regeneration in Asian patients exist.

Aims: The efficacy and safety of Profhilo in regenerating facial skin in Asian females were investigated in a single-center study.

Patients/methods: Patients were treated with Profhilo on Weeks 0 and 4 and followed up on Week 12. Assessments included three-dimensional photography, Facial Volume Loss Scale (FVLS), Wrinkle Severity Rating Scale (WSRS), superficial skin hydration, transepidermal water loss (TEWL), skin elasticity, and self-rated product tolerability.

Results: Of 30 enrolled Chinese females (aged 38.0-60.0 years), outcome data were analyzed for 28 and 26 patients at Weeks 0-4 and follow-up, respectively, aside from skin hydration (N = 8 and N = 6, respectively). Treatment led to a FVLS (P = 0.0150), WSRS (P = 0.0057), and R3 ("tiring effect" of the skin; P = 0.0424) decrease over time, but pairwise time point comparisons for these measures were not significant (NS). A trend toward a decrease in F1 (elasticity) over time occurred but was NS. A statistically significant improvement in superficial skin hydration and TEWL occurred over time (P = 0.0010 and P = 0.0055, respectively) and, specifically, at Week 12 versus baseline (P = 0.0034 and P = 0.0029, respectively). Patients reported "good" product tolerability.

Conclusions: Profhilo for facial skin regeneration was efficacious and tolerable in Chinese patients. This study contributes to the limited available clinical data with Profhilo and Asian facial skin regeneration. Profhilo significantly improved superficial skin hydration and transepidermal water loss in Chinese patients. Profhilo was well tolerated in Chinese patients.

Level Of Evidence Iv: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .