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

NCT06333782 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2024-08-09

No results posted yet for this study

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

Conditions

  • Vulvar Atrophy

Interventions

DEVICE

Experimental- Genefill Contour®

Genefill Contour® Hyaluronic Acid Injection

DEVICE

Marketed comparator - Desirial®Plus

DESIRIAL®PLUS Hyaluronic Acid Injection

Sponsors & Collaborators

  • Eurofins

    collaborator INDUSTRY

  • Bioscience Cosmetics SL

    lead INDUSTRY

Principal Investigators

  • Dalia Quwaider, PhD, MBA · Bioscience Cosmetics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-22
Primary Completion
2025-07-01
Completion
2025-07-01

Countries

  • France
  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06333782 on ClinicalTrials.gov