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

Study Overview
=================
Brief 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.

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

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

Intervention / Treatment
-----------------
* Device: Janesse 20 (Cross-linked Hyaluronic Acid)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with age ≥ 18. Women seeking genital rejuvenation with Genital Appearance Satisfaction Scale (GAS) >20 and Cosmetic Procedure Screening Scale modified for Labia (COPS-L)>40 . Patients with diagnosis of Body Dysmorphic Disorder (BDD) following DSM-IV criteria or congenital or post-menopausal Labia Majora hypotrophy • The Labia Majora (left and right) width and/or length must be between the 5th and 95th percentiles as reported in the Annex 4 of the protocol (modified table from Kreklau A e t al 2018). The measurement must be performed by the Investigators using the Sliding Zuricher Caliper mm130. Women willing to provide signed informed consent to clinical investigation participation. Exclusion Criteria: Use of aspirin and antiplatelet agents a week prior to treatment. Pregnant or lactating women. Women with history of allergy or hypersensitivity to the HA or to other ingredients of the dermal filler. Women with history of allergy or hypersensitivity to Lidocaine, Mepivacaine or Prilocaine or local anaesthetics. Women with any dermal systemic pathologies, such as systemic lupus erythematosus, psoriasis, scleroderma etc. Women presenting bleeding disorders in the past or present. Women taking or having indications for anticoagulant therapy. Use of concomitant treatments or procedures aimed to improve genital skin rejuvenation over the last six months before the clinical investigation enrolment, such as chemical peeling, dermabrasion, laser resurfacing. Women suffering from infectious diseases including herpes simplex virus infection, active hepatitis, Human Papilloma Virus (HPV) or Human Immunodeficiency Virus (HIV). Women suffering from local dermatitis (vulvar scaly papilloma, mycosis, bacterial infection near the injection area). Women at risk in term of precautions, warnings and contra-indications referred in the package insert of the clinical investigation device. Women with autoimmune diseases, streptococcus disease. Women with any active irritation or inflammation in the target areas of injection. Recent vulvae surgery in the treatment area or progressive recent or nearby cancers (i.e. cervical cancer). Tachycardia or other severe heart rhythm disorders Women with previous regional radiotherapy. Women who practice cycling or dedicate themselves to horse riding; women who practice bodybuilding or who perform professional sports. Women unlikely to cooperate in the clinical investigation or to comply with the treatment or with the clinical investigation visits. Performed dentist visit in the last week. Women participating in another clinical investigation or treated with another HA filler with the same indications at the same time or within the preceding 30 days.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Janesse 20<br> | Device: Janesse 20 (Cross-linked Hyaluronic Acid)<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Aesthetic Improvement Scale (GAIS) | Global Aesthetic Improvement Scale (GAIS) is will be evaluated by the investigator using standardized photos. The scale is using scores as 1= VERY MUCH IMPROVED, 2= MUCH IMPROVED, 3 = IMPROVED, 4 = NO CHANGE, 5= WORSE. The picture will be done at 60 days after the initiation of treatment with Janesse 20, will be compared with Baseline Visit (day 0) and one of the above-mentioned scores will be gibed used to indicate the changes after the treatment. | 60 days | 
| Overall safety | The overall safety will be evaluated by safety checklist for the patient (modified from Liu S, 2010) and the searching of Adverse Event (s), Adverse Device Event (s), Serious Adverse Event (s), Serious Adverse Device Event (s), Unanticipated Serious Adverse Device Event (s) and Device Deficiency at each visit. | up to 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dimensions of Labia Majora | The measurement will be performed with the subject in lithotomy position at the different visits using a Sliding Zuricher Caliper mm130 for length and width; the ultrasound technique will be used to evaluate the depth. | 30 days, 60 days | 
| Genital Appearance Satisfaction (GAS) | Genital Appearance Satisfaction (GAS) self-assessment of the subject to assess the change comparing the final and baseline value. The scale contains 11 statements regarding attitudes towards genital appearance. Each item is scored on a Likert scale between 0 (=NEVER) and 3 =(ALWAYS). Total scores range from 0 to 33. Higher scores represent greater dissatisfaction with the genitalia. | 30 days, 60 days | 
| Global Aesthetic Improvement Scale (GAIS) | Global Aesthetic Improvement Scale (GAIS) evaluated by blind Investigator, using scores 1= VERY MUCH IMPROVED, 2= MUCH IMPROVED, 3 = IMPROVED, 4 = NO CHANGE, 5= WORSE. | 30 days, 60 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Labia Majora, Genital rejuvenation, Hyaluronic Acid, Filler