Efficacy and Tolerability of a Hyaluronic Acid-Based Extracellular Matrix for Labia Majora Rejuvenation and Augmentation: A Pilot Study.

ABSTRACT

A new injectable solution containing low-molecular-weight hyaluronic acid (HA) and a specific amino acid mixture was formulated with proper aesthetic performance for the main signs of facial skin photoaging. The present study aimed to investigate its new application for rejuvenating and augmenting labia majora using clinical and biometric assessments. Three sessions of intradermal injections were performed using 3 ml of test extracellular matrix (ECM) for 10 eligible post-menopause female subjects (age 53.6 ± 7.93 years). The effectiveness of the intervention was assessed by an independent physician using before-and-after pictures based on the physician's global assessment score. Objective biophysical skin assessments, including skin hydration, skin erythema, and melanin index, as well as elasticity parameters including firmness (R0), gross elasticity (R2), and net elasticity (R5), were also performed before the first injection and then on the 2nd and 12th weeks after the last session. Patients' satisfaction and all reported or observed adverse events were documented. At week 12, all the subjects reported an aesthetic improvement of 25% or more in rejuvenation and sagging of the labia major area. A statistically significant improvement was also detected in R0 and R5 at week 12 (p-values 0.005 and 0.022, respectively). Patient satisfaction surveys revealed a median score of 8 at both follow-up visits. The results showed a new indication of the tested HA ECM for providing a beneficial, durable, rejuvenating effect on the labia majora with a good safety profile.