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Clinical Trial Summary

The use of hyaluronic acid (HA)-based fillers administered by injection to obtain Labia Majora augmentation is performed by many surgeons and gynaecologists in Europe, US and other countries, but few studies have investigated the effectiveness of this procedure. In this open not comparative study, 36 female subjects above or equal to 18 years old at inclusion, seeking genital rejuvenation, who have congenital or post-menopausal hypotrophy of the vulvar Labia Majora (or a diagnosis of Body Dysmorphic Disorder), who have given her informed consent and meet all the eligibility criteria, will be enrolled. Subjects will come to a total of 4 visits over a period of 2 months. The primary objective of the study is to evaluate the performance of the dermal filler by the Global Aesthetic Improvement Scale (GAIS) at day 60 and the safety during all the study. The secondary objectives are the evaluation of volume restoration of Labia Majora (measured by caliper and Ultrasound) and the subjective evaluation (by Genital Appearance Satisfaction Scale) at different visits.


Clinical Trial Description

n/a


Study Design


NCT number NCT04936763
Study type Interventional
Source I.R.A. Istituto Ricerche Applicate S.p.A.
Contact Dionisio F Barattini, MD Europe
Phone +40774012684
Email franco.barattini@tigermedgrp.com
Status Recruiting
Phase N/A
Start date May 28, 2021
Completion date August 2023