NCT04936763

To Assess The Performance And Tolerance Of Janesse 20 In The Volume Restoration Of Labia Majora

A Multicentre, Open-Label, Interventional, Trial To Assess The Performance And Tolerance Of Janesse 20 In The Volume Restoration Of Labia Majora

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: I.R.A. Istituto Ricerche Applicate S.p.A. · Network
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Dysmorphic Disorder (BDD)
• Congenital Labia Majora Hypotrophy
• Post-menopausal Labia Majora Hypotrophy

Interventions

Type	Name	Description
DEVICE	Janesse 20 (Cross-linked Hyaluronic Acid)	Janesse 20 will be administered at baseline (visit 2, day 0) and, if the Investigator will evaluate necessary, also at day 30 (visit 3). The Investigational device will be injected with retrograde technique (moving backward) with homogeneous amount on the length of each side of Labia Majora. The Janesse 20 dosage administered will be 1 ml in left labia and 1 ml in right labia for each session.

Timeline

• Start date: 2021-05-28
• Primary completion: 2023-06-01
• Completion: 2023-08-01
• First posted: 2021-06-23
• Last updated: 2022-07-15

Locations

2 sites across 2 countries: Italy, Romania