Evaluation of the Efficacy and Safety of the Dermal Filler for Augmentation of Labia Majora.
- Conditions
- Labia Majora Atrophy and Hypotrophy
- Registration Number
- NCT04652817
- Lead Sponsor
- Mesoestetic Pharma Group S.L.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 35
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Treatment-Emergent Adverse Events [Safety and Tolerability] From screening through study completion, an average of 90 days - daily. Frequency and severity of adverse events (AEs) and adverse device effects.
Visual Analogous Scale (VAS) absolute change From Day 0 (Session 1) to Day 60 (Session 3) - up to 8 weeks. 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.
- Secondary Outcome Measures
Name Time Method Visual Analogous Scale (VAS) 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). 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.
Global Aesthetic Improvement Scale (GAIS) From Day 0 (immediately after application) to Days 30, 60 and 90 (up to 4 weeks, 8 weeks and 12 weeks respectively). 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.
Subject satisfaction Days 0 (immediately after application), 30, 60 and 90 (up to 4 weeks, 8 weeks and 12 weeks respectively). 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.
Trial Locations
- Locations (1)
Medical Centre Ramus
🇧🇬Sofia, Bulgaria
Medical Centre Ramus🇧🇬Sofia, Bulgaria