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

Primary Purpose

Vaginal Atrophy, Vulvovaginal Signs and Symptoms, Dyspareunia

Status
Completed
Phase
Not Applicable
Locations
Bulgaria
Study Type
Interventional
Intervention
MMG-23-04-2019
Sponsored by
Mesoestetic Pharma Group S.L.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vaginal Atrophy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Medical Centre Ramus

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MMG-23-04-2019

Arm Description

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.

Outcomes

Primary Outcome Measures

Vaginal Maturation Index (VMI) absolute change
Improvement in the properties of the vaginal wall, measured by the VMI.
Treatment-Emergent Adverse Events [Safety and Tolerability]
Frequency and severity of adverse events (AEs) and adverse device effect

Secondary Outcome Measures

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.
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.
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.
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).
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)
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).
Viganal biopsy (optional)
Evaluation of the mitotic activity of the mucosa (Ki-67 proliferation marker - %).
Participant's Questionnaire
To register the overall discomfort and satisfaction of the subjects.

Full Information

First Posted
November 20, 2020
Last Updated
December 2, 2020
Sponsor
Mesoestetic Pharma Group S.L.
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1. Study Identification

Unique Protocol Identification Number
NCT04659668
Brief Title
Evaluation of the Efficacy and Safety of the Dermal Filler for Female Intimate Area Hydration and Atrophy of the Vagina.
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
November 11, 2019 (Actual)
Primary Completion Date
June 12, 2020 (Actual)
Study Completion Date
August 17, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mesoestetic Pharma Group S.L.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 "MMG-23-04-2019" on the female genital area for the medicinal, functional and reconstructive indications.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginal Atrophy, Vulvovaginal Signs and Symptoms, Dyspareunia, Urinary Incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MMG-23-04-2019
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
MMG-23-04-2019
Intervention Description
The dermal filler MMG-23-04-2019 is applied to the female intimate area (intramucosal administration) of vaginal vestibule, vaginal walls, clitoris, "G" spot.
Primary Outcome Measure Information:
Title
Vaginal Maturation Index (VMI) absolute change
Description
Improvement in the properties of the vaginal wall, measured by the VMI.
Time Frame
From baseline to Day 60 (up to 8 weeks).
Title
Treatment-Emergent Adverse Events [Safety and Tolerability]
Description
Frequency and severity of adverse events (AEs) and adverse device effect
Time Frame
From screening through study completion, an average of 60 days - daily.
Secondary Outcome Measure Information:
Title
The change in the Gloria Bachmann Vaginal Health Index (VHI)
Description
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).
Title
The absolute change in Visual Analogous Scale (VAS).
Description
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).
Title
The absolute change in Visual Analogous Scale (VAS)
Description
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).
Title
The change of the Female Sexual Function Index (FSFI) score.
Description
The FSFI is a validated questionnaire to measure the sexual functioning of women. The score ranges between 2 (minimum) and 36 (maximum).
Time Frame
From Day 0 to Day 30 and Day 60 (up to 4 weeks and 8 weeks respectively).
Title
Subject satisfaction evaluated by the Global Impression of Improvement (PGI-I) questionnaire
Description
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).
Title
The change if the Nugent Score
Description
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).
Title
Viganal biopsy (optional)
Description
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).
Title
Participant's Questionnaire
Description
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).

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Gender-based pathology.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Medical Centre Ramus
City
Sofia
ZIP/Postal Code
1592
Country
Bulgaria

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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