Clinical trial NCT04936763: To Assess The Performance And Tolerance Of Janesse 20 In The Volume Restoration Of Labia Majora
Official title: A Multicentre, Open-Label, Interventional, Trial To Assess The Performance And Tolerance Of Janesse 20 In The Volume Restoration Of Labia Majora
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dysmorphic Disorder (BDD)
Congenital Labia Majora Hypotrophy
Post-menopausal Labia Majora Hypotrophy
Keywords: Labia Majora
Genital rejuvenation
Hyaluronic Acid
Filler
Lead sponsor: I.R.A. Istituto Ricerche Applicate S.p.A.
Sponsor class: NETWORK
Collaborators: name: Opera CRO, a TIGERMED Group Company
First posted: 2021-06-23
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Global Aesthetic Improvement Scale (GAIS)
timeFrame: 60 days
measure: Overall safety
timeFrame: up to 60 days
Secondary outcomes:
measure: Dimensions of Labia Majora
timeFrame: 30 days, 60 days
measure: Genital Appearance Satisfaction (GAS)
timeFrame: 30 days, 60 days
measure: Global Aesthetic Improvement Scale (GAIS)
timeFrame: 30 days, 60 days
Other outcomes:
measure: Explorative outcome (Labia Majora volume)
timeFrame: 30 days, 60 days
Locations:
city: Genova
country: Italy
facility: Villa Serena
city: Timişoara
country: Romania
facility: SCM Dr Rosu
Study officials:
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