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

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 orcongenital 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 fromKreklau A e t al 2018). The measurement must be performed by the Investigators usingthe Sliding Zuricher Caliper mm130.
• Women willing to provide signed informed consent to clinical investigationparticipation.

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 ofthe dermal filler.
• Women with history of allergy or hypersensitivity to Lidocaine, Mepivacaine orPrilocaine 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 rejuvenationover the last six months before the clinical investigation enrolment, such as chemicalpeeling, 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, bacterialinfection near the injection area).
• Women at risk in term of precautions, warnings and contra-indications referred in thepackage 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 practicebodybuilding or who perform professional sports.
• Women unlikely to cooperate in the clinical investigation or to comply with thetreatment or with the clinical investigation visits.
• Performed dentist visit in the last week.
• Women participating in another clinical investigation or treated with another HAfiller with the same indications at the same time or within the preceding 30 days.