Safety and Efficacy of a "High and Low Molecular Weight Hyaluronic Acid Hybrid Complex" Injection for Face Rejuvenation.

INTRODUCTION

Hyaluronic acid (HA)-based formulations could have remarkable efficacy in treating a wide range of skin defects, including skin aging. The purpose of the study was the evaluation of the clinical safety and efficacy of a high and low molecular weight HA hybrid complex injection for skin rejuvenation.

METHOD

In this single-arm, before-and-after clinical study, 20 subjects with wrinkled, dry, or rough skin were enrolled. They received two treatment sessions, each of 2 mL of stabilized high- and low-molecular-weight HA through intradermal injections in five bioaesthetic points with an interval of 4 weeks. Efficacy assessment measures included biophysical and sonographic parameters and the Global Aesthetic Improvement Scale (GAIS) score. Pain assessment, safety profile, and subject satisfaction were also reported.

RESULTS

A significant improvement in skin firmness was demonstrated in both follow-up visits. The Transepidermal water loss (TEWL) and the dermis ecodensity improved significantly in the first follow-up visit. A statistically significant increase in the dermis thickness was seen in the second follow-up visit. The median GAIS score indicated an average improvement of 51%-75%. The median overall satisfaction score was 7 and 6 in the first and second follow-up visits. No important side effects were observed. The average pain VAS score was 2 out of 10.

CONCLUSION

This new HA-based formulation is a safe and efficient treatment option to restore the vitality and turgidity of the skin.

TRIAL REGISTRATION

ClinicalTrials.gov identifier: IRCT20150101020514N17 with ethics code IR.TUMS.TIPS.REC.1401.083.