The study is an open-label uncontrolled single-center study for the evaluation of the Performance characteristics (efficacy and safety) of the dermal filler "MMG-23-04-2019" on the female genital area for the medicinal, functional and reconstructive indications.
The Dermal Filler is recommended for the female intimate areas, especially the internal area of the vagina (vaginal vestibule, introitus, vaginal walls, clitoris, "G" spot) for the following indications: vaginal dryness or discomfort, vaginal atrophy. The main functional ingredient is cross-linked hyaluronic acid of non-animal origin, produced through bacterial fermentation. The MMG-23-04-2019 is contained in pre-filled, graduated and disposable sterile syringe with Luer Lock adapter with 1 ml of net content and 20 mg/ml hyaluronic acid. The MMG-23-04-2019 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
37
The dermal filler MMG-23-04-2019 is applied to the female intimate area (intramucosal administration) of vaginal vestibule, vaginal walls, clitoris, "G" spot.
Medical Centre Ramus
Sofia, Bulgaria
Vaginal Maturation Index (VMI) absolute change
Improvement in the properties of the vaginal wall, measured by the VMI.
Time frame: From baseline to Day 60 (up to 8 weeks).
Treatment-Emergent Adverse Events [Safety and Tolerability]
Frequency and severity of adverse events (AEs) and adverse device effect
Time frame: From screening through study completion, an average of 60 days - daily.
The change in the Gloria Bachmann Vaginal Health Index (VHI)
The VHI is a score formed by 5 parameters (vaginal elasticity, vaginal secretions, pH, epithelial mucous membrane, vaginal hydration). The final score defines the degree of atrophy in the genitourinary tract by assigning a single score to each parameter. The maximum possible score is 25, while the minimum possible score is 5.
Time frame: From baseline to Day 30 (4 weeks) and Day 60 (up to 8 weeks).
The absolute change in Visual Analogous Scale (VAS).
The absolute change in VAS, ranged between 0 (no pain) and 10 (worst possible pain), judged by the Principal Investigator.
Time frame: From baseline to Day 30 (4 weeks) and Day 60 (up to 8 weeks).
The absolute change in Visual Analogous Scale (VAS)
The absolute change in VAS ranged between 0 (no pain) and 10 (worst possible pain), judged by the subject.
Time frame: From Day 0 to Day 30 (4 weeks) and Day 60 (up to 8 weeks).
The change of the Female Sexual Function Index (FSFI) score.
The FSFI is a validated questionnaire to measure the sexual functioning of women. The score ranges between 2 (minimum) and 36 (maximum).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: From Day 0 to Day 30 and Day 60 (up to 4 weeks and 8 weeks respectively).
Subject satisfaction evaluated by the Global Impression of Improvement (PGI-I) questionnaire
The PGI-I is a transition single question scale, asking the patient to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment on a scale from 1 (Very much better) to 7 (Very much worse)
Time frame: From Day 30 (4 weeks) to Day 60 (up to 8 weeks).
The change if the Nugent Score
The Nugent Score is a Gram stain scoring system for vaginal swabs to diagnose bacterial vaginosis, relying on scoring of individual types of organisms; a score of 0 to 10 is derived from a weighted combination of the following: large Gram-positive rods (lactobacilli; decrease in Lactobacillus scored as 0 to 4), small Gram-negative or Gram-variable rods (G. vaginalis or other anaerobes; scored as 0 to 4), and curved Gram-negative or Gram-variable rods (Mobiluncus spp.; scored as 0 to 2).
Time frame: From baseline to Day 60 (up to 8 weeks).
Viganal biopsy (optional)
Evaluation of the mitotic activity of the mucosa (Ki-67 proliferation marker - %).
Time frame: From Day 0 up to Day 60 (up to 8 weeks).
Participant's Questionnaire
To register the overall discomfort and satisfaction of the subjects.
Time frame: From Day 0 to Day 30 and Day 60 (up to week 4 and 8 respectively).