Evaluation of the Efficacy and Safety of the Dermal Filler for Female Intimate Area Hydration and Atrophy of the Vagina.

An Open-Label Uncontrolled Single Centre Study for the Evaluation of the Performance Characteristics (Efficacy and Safety) of the Dermal Filler MMG-23-04-2019 (Hyaluronic Acid 2,0%) for Female Intimate Area Hydration and Atrophy of the Vagina.

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.

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence; Vaginal Atrophy; Vulvovaginal Signs and Symptoms; Dyspareunia
• Intervention / Treatment: Device: MMG-23-04-2019

Detailed Description

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
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Bulgaria
  • Sofia, Bulgaria, 1592
    • Medical Centre Ramus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Female subject aged ≥18;
• Subject presenting vaginal atrophy, dryness, dyspareunia or discomfort in the intimate area;
• Subject who presents no other type of pathology of the area to be treated;
• Subject who is willing to abstain from any cosmetic or surgical procedures in the treatment area during the clinical investigation;
• Subject who is willing to participate in all study related activities and who is available for the duration of their participation in the investigation for follow-up;
• Absence of a history of significant hypersensitivity to food and drugs or known sensitivity to hyaluronic acid;
• Clinically and anamnestic healthy individual;
• 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;
• An axillar body temperature of up to 37 degrees celsius;
• 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;
• A 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 a history of vulvar cancer and/or previous regional radiotherapy;
• Subject with genital prolapse with a surgical indication or stress incontinence with a surgical indication;
• A subject who suffers from vaginism;
• Subject with genital bleeding of unknown origin;
• Subject with frequent or present active herpes simplex or herpes zoster local infection or active herpes simplex or herpes zoster infection in other sites;
• Subject with a history of frequent or active local dermatitis (of the injection site), vulvar scaly papilloma, mycosis; bacterial infection or laboratory tests indicating for such;
• A subject suffering from autoimmune diseases or who are undergoing treatment with immunosuppressors or immunotherapy;
• Subject with uncontrolled systemic diseases or who are undergoing current treatment with antihypertensives, steroid anti-inflammatory drugs anticoagulants, aspirin, major antidepressants;
• Pregnancy, postpartum period (6 months), lactation or post-lactation period (6 months);
• Absence of a reliable and effective method of contraception for a subject with childbearing potential;
• Subjects who are currently receiving another investigational treatment or who had participated in another clinical investigation within 30 days prior to study enrollment;
• A subject who suffer from another medical condition or who are receiving medication that in the Principal Investigator's judgment would prohibit the inclusion in the study;
• Subject with limited mental activity and consistent comprehension ability; sportsmen and individuals on strenuous physical loading; prisoners;
• Refusal to sign the Informed Consent Form.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: MMG-23-04-2019; MMG-23-04-2019 is composed by sodium hyaluronate at concentration of 2% (20 mg/ml) with 1,4-Butanediol diglycidyl ether (BDDE) acting as a cross-linking agent, in aqueous solution at physiological pH. The filler of 1ml is administered once or twice depending on the individual necessity.	Device: MMG-23-04-2019; The dermal filler MMG-23-04-2019 is applied to the female intimate area (intramucosal administration) of vaginal vestibule, vaginal walls, clitoris, "G" spot.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vaginal Maturation Index (VMI) absolute change	Improvement in the properties of the vaginal wall, measured by the VMI.	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	From screening through study completion, an average of 60 days - daily.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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).	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)	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).	From baseline to Day 60 (up to 8 weeks).
Viganal biopsy (optional)	Evaluation of the mitotic activity of the mucosa (Ki-67 proliferation marker - %).	From Day 0 up to Day 60 (up to 8 weeks).
Participant's Questionnaire	To register the overall discomfort and satisfaction of the subjects.	From Day 0 to Day 30 and Day 60 (up to week 4 and 8 respectively).

Collaborators and Investigators

• Sponsor: Mesoestetic Pharma Group S.L.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 11, 2019
• Primary Completion (ACTUAL): June 12, 2020
• Study Completion (ACTUAL): August 17, 2020

Study Registration Dates

• First Submitted: November 20, 2020
• First Submitted That Met QC Criteria: December 2, 2020
• First Posted (ACTUAL): December 9, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 9, 2020
• Last Update Submitted That Met QC Criteria: December 2, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Pathological Conditions, Anatomical; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Urinary Incontinence; Atrophy; Dyspareunia
• Other Study ID Numbers: MD/MMG-23-04-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No