NCT06333782

Evaluation of the Safety and Efficacy of Hyaluronic Acid Injection in Labia Majora Augmentation

Prospective, Multicentric, Single Blind, Randomized Study on the Evaluation of the Safety and Efficacy of Genefill Contour® Versus Comparator in Labia Majora Augmentation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Bioscience Cosmetics SL · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The goal of this interventional clinical investigation using Genefill Contour® CE marked device outside of its indication is to compare with other hyaluronic acid device already marketed for labia majora augmentation in women with labia majora hypotrophy/atrophy. The primary objective is the evaluation of the safety of Genefill Contour®. The secondary objectives is effectivenes of the investigational device (improvement of patient´s symptoms, patient´s satisfaction, sexual function \& pain during injection). Participants will come to a total of 8 visits (including 2 phone calls) over a period of 12 months. Participants would be enrolled in Genefill Contour® or comparator group. An ancillary study would be conducted in a cohort of participants evaluating the increase in volume and distance between labia after HA injection

Detailed description

Prospective, Multicentric, Single Blind, Randomized study on the evaluation of the safety and efficacy of Genefill Contour versus comparator in labia majora augmentation. This study analyze the safety and efficacy of the investigational device versus comparator. Participants would be randomized 1:1 between 2 arms (Genefill Contour vs comparator). The study duration is 12 months and will consist in 8 visits (Screening visit, 5 on site visit and 2 phone calls). At week 4, an optional touch-up may be conducted. 110 participants are expected to be included in the trial. The primary objective is the evaluation of the safety of Genefill Contour®. The secondary objectives is effectivenes of the investigational device (improvement of patient´s symptoms, patient´s satisfaction, sexual function \& pain during injection). An ancillary study would be conducted in a cohort of participants evaluating the increase in volume and distance between labia after HA injection at W4 and W12.

Conditions

• Vulvar Atrophy

Interventions

Type	Name	Description
DEVICE	Experimental- Genefill Contour®	Genefill Contour® Hyaluronic Acid Injection
DEVICE	Marketed comparator - Desirial®Plus	DESIRIAL®PLUS Hyaluronic Acid Injection

Timeline

• Start date: 2024-05-22
• Primary completion: 2025-07-01
• Completion: 2025-07-01
• First posted: 2024-03-27
• Last updated: 2024-08-09

Locations

3 sites across 2 countries: France, Poland