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

July 14, 2022 updated by: I.R.A. Istituto Ricerche Applicate S.p.A.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Genova, Italy
        • Not yet recruiting
        • Villa Serena
        • Principal Investigator:
          • Andrea Maria Scarpa, MD
  • Romania
      • Timişoara, Romania
        • Recruiting
        • Scm Dr Rosu
        • Principal Investigator:
          • Florina Todorut, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Janesse 20
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global Aesthetic Improvement Scale (GAIS)
Time Frame: 60 days

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
Time Frame: up to 60 days
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
Time Frame: 30 days, 60 days
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)
Time Frame: 30 days, 60 days
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)
Time Frame: 30 days, 60 days
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Explorative outcome (Labia Majora volume)
Time Frame: 30 days, 60 days

The validation of measurements of Labia Majora volume by a 3D software during the study period comparing these values with the dimensions obtained with ultrasound (for depth) and caliper (for lenght and width).

Tridimensional surface imaging for estimating Labia Majora volume using Crisalix iPad App and the Crisalix 3D Surface Imager Camera will be evaluated by blind Investigator at different visits. The data will be collected and evaluated in 1 center only (Genova).
30 days, 60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

I.R.A. Istituto Ricerche Applicate S.p.A.

Collaborators

Opera CRO, a TIGERMED Group Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 28, 2021

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

August 1, 2023

Study Registration Dates

First Submitted

May 31, 2021

First Submitted That Met QC Criteria

June 22, 2021

First Posted (Actual)

June 23, 2021

Study Record Updates

Last Update Posted (Actual)

July 15, 2022

Last Update Submitted That Met QC Criteria

July 14, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPIRA/0619/MD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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