Back to resultsEvaluation of the Efficacy and Safety of the Dermal Filler for Augmentation of Labia Majora.
Primary Purpose
Labia Majora Atrophy and Hypotrophy
Status
Completed
Phase
Not Applicable
Locations
Bulgaria
Study Type
Interventional
Intervention
MMI-22-04-2019
Sponsored by
About this trial
This is an interventional treatment trial for Labia Majora Atrophy and Hypotrophy
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Medical Centre Ramus
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MMI-22-04-2019
Arm Description
Sodium hyaluronate at a concentration of 2.5% (25 mg/ml) with 1,4-Butanediol diglycidyl ether (BDDE) acting as a cross-linking agent administered once or twice depending on the individual necessity.
Outcomes
Primary Outcome Measures
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.
Treatment-Emergent Adverse Events [Safety and Tolerability]
Frequency and severity of adverse events (AEs) and adverse device effects.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT04652817
First Posted
February 20, 2020
Last Updated
December 2, 2020
Sponsor
Mesoestetic Pharma Group S.L.
1. Study Identification
Unique Protocol Identification Number
NCT04652817
Brief Title
Evaluation of the Efficacy and Safety of the Dermal Filler for Augmentation of Labia Majora.
Official Title
An Open-Label Uncontrolled Single Centre Study for the Evaluation of the Performance Characteristics (Efficacy and Safety) of the Dermal Filler MMI-22-04-2019 (Hyaluronic Acid 2,5%) for Female Intimate Area Augmentation of Labia Majora.
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
July 12, 2020 (Actual)
Study Completion Date
August 26, 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 "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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labia Majora Atrophy and Hypotrophy
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
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MMI-22-04-2019
Arm Type
Experimental
Arm Description
Sodium hyaluronate at a concentration of 2.5% (25 mg/ml) with 1,4-Butanediol diglycidyl ether (BDDE) acting as a cross-linking agent administered once or twice depending on the individual necessity.
Intervention Type
Device
Intervention Name(s)
MMI-22-04-2019
Intervention Description
A cross-linked form of the Hyaluronic Acid is used in intradermal injection to augment the labia majora area.
Primary Outcome Measure Information:
Title
Visual Analogous Scale (VAS) absolute change
Description
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.
Title
Treatment-Emergent Adverse Events [Safety and Tolerability]
Description
Frequency and severity of adverse events (AEs) and adverse device effects.
Time Frame
From screening through study completion, an average of 90 days - daily.
Secondary Outcome Measure Information:
Title
Visual Analogous Scale (VAS)
Description
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).
Title
Global Aesthetic Improvement Scale (GAIS)
Description
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).
Title
Subject satisfaction
Description
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).
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 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.
Exclusion Criteria:
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.
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 Augmentation of Labia Majora.
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