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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
A cross-linked form of the Hyaluronic Acid is used in intradermal injection to augment the labia majora area.
Medical Centre Ramus
Sofia, Bulgaria
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.
Time frame: 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.
Time frame: From screening through study completion, an average of 90 days - daily.
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.
Time frame: 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.
Time frame: 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.
Time frame: Days 0 (immediately after application), 30, 60 and 90 (up to 4 weeks, 8 weeks and 12 weeks respectively).
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