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Evaluation of the Safety and Efficacy of Hyaluronic Acid Injection in Labia Majora Augmentation
Sponsor: Bioscience Cosmetics SL
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
Experimental- Genefill Contour®
Genefill Contour® Hyaluronic Acid Injection
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