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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
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.

Conditions
-----------------
Labia Majora Atrophy and Hypotrophy

Intervention / Treatment
-----------------
* Device: MMI-22-04-2019


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

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

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

Accepts Healthy Volunteers
-----------------
No

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MMI-22-04-2019<br>Sodium hyaluronate at a concentration of 2.5% (25 mg/ml) with 1,4-Butanediol diglycidyl ether (BDDE) acting as a cross-linking agent administered once or twice depending on the individual necessity. | Device: MMI-22-04-2019<br>* A cross-linked form of the Hyaluronic Acid is used in intradermal injection to augment the labia majora area.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogous Scale (VAS) absolute change | The absolute change in VAS, judged by the Principal Investigator. VAS ranged between 0 (least satisfied) and 10 (most satisfied) is used. The higher the score, the better the cosmetic appearance. | From Day 0 (Session 1) to Day 60 (Session 3) - up to 8 weeks. | 
| Treatment-Emergent Adverse Events [Safety and Tolerability] | Frequency and severity of adverse events (AEs) and adverse device effects. | From screening through study completion, an average of 90 days - daily. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogous Scale (VAS) | The absolute change in VAS, judged by the Principal Investigator. VAS ranged between 0 (least satisfied) and 10 (most satisfied) is used. The higher the score, the better the cosmetic appearance. | From Day 0 (Session 1) to Day 0 (immediately after application), 30 (up to 4 weeks) and 90 (up to 12 weeks) (Session 1, 2 and 4). | 
| Global Aesthetic Improvement Scale (GAIS) | The change in GAIS as evaluated by the PI based on the photographs of the treated area. A 5-point scale rating improvement in appearance compared to pre-treatment - 1 being exceptional improvement and 5 being worsened. | From Day 0 (immediately after application) to Days 30, 60 and 90 (up to 4 weeks, 8 weeks and 12 weeks respectively). | 
| Subject satisfaction | Subject satisfaction based on Questionnaire, including visual analogue scale, ranged between 0 (least satisfied) and 10 (most satisfied) is used and questions about discomfort and satisfaction. | Days 0 (immediately after application), 30, 60 and 90 (up to 4 weeks, 8 weeks and 12 weeks respectively). |