Evaluation of the Efficacy and Safety of the Dermal Filler for Augmentation of Labia Majora.

An Open-Label Uncontrolled Single Centre Study for the Evaluation of the Performance Characteristics (Efficacy and Safety) of the Dermal Filler MMI-22-04-2019 (Hyaluronic Acid 2,5%) for Female Intimate Area Augmentation of Labia Majora.

The study is an open-label uncontrolled single-center study for the evaluation of the Performance characteristics (efficacy and safety) of the dermal filler "MMI-22-04-2019" on the female genital area for the aesthetic, medicinal, functional and reconstructive indications.

MMI-22-04-2019 is a dermal filler recommended for application in the intimate area. It is a sterile, injectable, colorless transparent gel, non-pyrogenic, reabsorbable medical device. Its main functional ingredient is cross-linked hyaluronic acid of non-animal origin, produced through bacterial fermentation.

The MMI-22-04-2019 is contained in pre-filled, graduated, disposable sterile syringe with Luer Lock adapter with 1 ml of net content. The sterilization of the product is achieved by moist heat.

The MMI-22-04-2019 has been classified as a Class III medical device under Annex IX of Directive MDD 93/42 EEC since it is a long-term, invasive and absorbable medical device.

Inclusion Criteria:

• Female subject aged ≥18;
• Subject presenting vulvar ptosis, deflation or aesthetic discomfort in the intimate area;
• Subject who presents no type of pathology of the area to be treated;
• Subjects who are willing to abstain from any cosmetic or surgical procedures in the treatment area during the clinical investigation;
• Clinically and anamnestically healthy individual;
• Absence of a history of significant hypersensitivity to food and drugs or known sensitivity to hyaluronic acid;
• Arterial blood pressure (BP) (after 5 min. at rest in the supine position) systolic 90 - 140 mmHg and diastolic 50 - 90 mmHg;
• Heart rate (HR) (after 5 min. at rest in the supine position) over 50 beats/min and less than 90 beats/min;
• Respiratory rate between 12 - 24 breaths/min;
• Axillar body temperature of up to 370С;
• Clinical-laboratory examinations within the reference ranges or with no clinically significant abnormalities;
• Negative AIDS/HIV test;
• Negative pregnancy test for the women with reproductive potential;
• Reliable and acceptable method of contraception for the women of child-bearing potential
• Signed written Informed Consent Form.

Exclusion Criteria:

• Subject with known sensitivity to hyaluronic acid or significant hypersensitivity to food and drugs;
• Subject with history of vulvar cancer and/or previous regional radiotherapy;
• Subjects with frequent or present active herpes simplex or herpes zoster local infection or active herpes simplex or herpes zoster infection in other sites;
• Subjects with history of frequent or active local dermatitis (of the injection site), vulvar scaly papilloma, mycosis; bacterial infection;
• Subjects suffering from autoimmune diseases or who are undergoing treatment with immunosuppressors or immunotherapy;
• Subjects uncontrolled systemic diseases;
• Pregnancy, postpartum period (6 months) or post-lactation period (6 months);
• Absence of a reliable and effective method of contraception;
• Subjects who are currently receiving another investigational treatment or who had participated in another clinical investigation within 30 days prior to study enrollment;
• Subjects who suffer from another medical condition or who are receiving medication that in the Principal Investigator's judgment would prohibit inclusion in the study;
• Subjects with limited mental activity and consistent comprehension ability; sportsmen and individuals on strenuous physical loading; prisoners;
• Refusal to sign the Informed Consent Form.