Evaluation of the Efficacy and Safety of Hyaluronic Acid Injection for Volume Restoration of the Labia Majora: ESOLANE study.

Introduction and hypothesis: Labia majora atrophy and protrusion of the labia minora beyond the labia majora is a concern for an increasing number of women who consider it aesthetically and, sometimes, functionally unsatisfactory. The ESOLANE study was a multicenter clinical investigation designed to collect effectiveness and safety data on DESIRIAL® PLUS injected subcutaneously in the labia majora in participants seeking labia majora volume deficits correction.

Methods: A prospective, uncontrolled, open-label multicenter study was conducted between November 2019 and December 2021. Seventy-three women with labia majora hypotrophy or atrophy and requesting labia majora volume restoration were enrolled and 72 were treated. Outcome measures were collected at baseline, then 4, 12, 24, 36, and 52 weeks post treatment. Primary endpoint was the proportion of patients' who reported aesthetic improvement on the global aesthetic improvement scale (GAIS) 12 weeks after initial injection. Secondary endpoints were assessments of patients' and investigators' who reported GAIS, patient sexual function and physical symptoms, patient satisfaction, and safety.

Results: According to the patients' who reported GAIS, 97% rated themselves as improved 12 weeks following the initial treatment. Improvement levels were high throughout the 52-week follow-up period with rates > 92%. Improvements were also confirmed on investigators' assessments with rates > 86%. Furthermore, patients reported significantly improved sexual function, symptom reduction, and high satisfaction. DESIRIAL® PLUS was well tolerated.

Conclusions: DESIRIAL® PLUS is an effective and safe treatment option in patients with labia majora hypotrophy or atrophy. This effect goes beyond aesthetic improvement, as treatment was associated with improvement in patients' physical symptoms and sexual function.