Evaluation of the Efficacy and Safety of Hyaluronic Acid Injection in Labia Majora for Volume Restoration — ESOLANE  

Vulvar Atrophy Clinical Trial

Official title: Evaluation of the Efficacy and Safety of Hyaluronic Acid Injection in Labia Majora for Volume Restoration

Status Completed

Clinical Trial Summary

DESIRIAL® PLUS is a CE-marketed hyaluronic acid (since 2011) whose registered indications are moderate hypotrophy, severe hypotrophy or atrophy of the vulvar Labia Majora by subcutaneous injections. The aim is to restore volume, rehydrate and add tone and tension to connective tissue areas by filling.

In this study, 71 female subjects above or equal to 18 years old at inclusion, who have moderate hypotrophy or severe hypotrophy or atrophy of the vulvar Labia Majora (according to investigator's judgement), who have given her informed consent and meet all the eligibility criteria, will be enrolled. Subjects will come to a total of 6 visits over a period of 12 months. An optional screening visit may be done before injection (additional visit). Proportion of patients having an improved perception of aesthetics (GAIS score after mirror self-examination) after baseline injection will be assessed. Global Aesthetic Improvement, Sexual function, subject's satisfaction, subject's symptoms, pain at injection and safety will be also assessed.

Clinical Trial Description

ESOLANE is a prospective multicenter post-marketing study of a class III medical device. This uncontrolled open-label study investigates the efficacy and safety of DESIRIAL® PLUS in volume restoration of Labia Majora. The study duration is 12 months with an optional screening visit (V0) up to 14 days before injection, the baseline visit (injection of DESIRIAL®PLUS, V1) and 5 follow-up visits after 4, 12, 24, 36 and 52 weeks (V2 to V6). At 4 weeks (V2) an optional touch-up may be done (if needed). It is envisaged to enrol 71 female patients with the wish for volume restoration in France to obtain at least 60 evaluable patients, which will be monitored over 1 year after baseline injection of DESIRIAL® PLUS.

The primary endpoint is defined as the proportion of patients having an improved perception of aesthetics (GAIS score after mirror self-examination) at 12 weeks after baseline injection of DESIRIAL® PLUS, which may be touched-up once after 4 weeks (V2).

Global Aesthetic Improvement (evaluated by the patient and the doctor), Sexual function, subject's satisfaction, subject's symptoms & pain, will be measured at all time-point with a Global Aesthetic Improvement Scale (GAIS), Female Sexual Function Index (FSFI), patient's satisfaction questionnaire (PSQ) and a Numerical Rating Scale (NRS) respectively. Safety will be also assessed. ;

Related Conditions & MeSH terms

• Atrophy
• Vulvar Atrophy

• NCT number: NCT04147689
• Study type: Interventional
• Source: Laboratoires Vivacy
• Status: Completed
• Phase: N/A
• Start date: November 18, 2019
• Completion date: March 30, 2022