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RECRUITING
NCT06333782
NA

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

Sponsor: Bioscience Cosmetics SL

View on ClinicalTrials.gov

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

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

110

Start Date

2024-05-22

Completion Date

2025-07-01

Last Updated

2024-08-09

Healthy Volunteers

Yes

Conditions

Interventions

DEVICE

Experimental- Genefill Contour®

Genefill Contour® Hyaluronic Acid Injection

DEVICE

Marketed comparator - Desirial®Plus

DESIRIAL®PLUS Hyaluronic Acid Injection

Locations (3)

Cabinet renaissance

Levallois-Perret, Paris, France

Palais Flore

Lyon, France

Medical Center "Tu sie leczy"

Gdansk, Gdansk, Poland