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

NACompletedINTERVENTIONAL
Enrollment

72

Participants

Timeline

Start Date

November 18, 2019

Primary Completion Date

February 25, 2021

Study Completion Date

March 30, 2022

Conditions
Vulvar Atrophy
Interventions
DEVICE

DESIRIAL® PLUS

"DESIRIAL® PLUS is a cross-linked hyaluronic acid gel to restore volume by filling the labia majora, to rehydrate and to add tone and tension to the area of connective tissue.~The baseline injection is performed at V1, with a maximum volume to be injected per labium of 2 ml. The exact volume will be determined by the physician in order to reach optimal volume correction.~One optional touch-up injection of DESIRIAL® PLUS is allowed at V2 (4 weeks after Baseline), with a maximum volume to be injected per labium of 1 ml. No other touch-up injections are allowed until the end of the study."

Trial Locations (9)

13008

Private office, Marseille

44000

Centre de la femme, Nantes

66000

Private office, Perpignan

69004

CHU Croix-Rousse, Lyon

75007

Private office, Paris

75017

Private office, Paris

76100

Clinique de l'Europe, Rouen

93260

Private office, Les Lilas

94000

Chu Henri Mondor, Créteil

Sponsors
All Listed Sponsors
lead

Laboratoires Vivacy

INDUSTRY