Labia Majora Atrophy and HypotrophyNCT04652817
Evaluation of the Efficacy and Safety of the Dermal Filler for Augmentation of Labia Majora.
A study testing MMI-22-04-2019 in people with Labia Majora Atrophy and Hypotrophy, run by Mesoestetic Pharma Group S.L. at 1 site in Bulgaria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Labia Majora Atrophy and Hypotrophy
- What is being tested?
- MMI-22-04-2019
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteBulgaria
- Study dates
- 11 Nov 2019to 26 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Labia Majora Atrophy and Hypotrophy
- Being tested
- MMI-22-04-2019
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MMI-22-04-2019Device
A cross-linked form of the Hyaluronic Acid is used in intradermal injection to augment the labia majora area.
| Study group | Role | What they receive |
|---|---|---|
| MMI-22-04-2019 | Experimental | 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. Receives: Device: MMI-22-04-2019 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From screening through study completion, an average of 90 days - daily.
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Days 0 (immediately after application), 30, 60 and 90 (up to 4 weeks, 8 weeks and 12 weeks respectively).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start11 Nov 2019
- Primary completion12 Jul 2020
- Study completion26 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labia Majora Atrophy and HypotrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mesoestetic Pharma Group S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04652817
- Sponsor's protocol ID
- MD/MMI-22-04-2019
- Status last verified
- Dec 2020
- First submitted
- 20 Feb 2020
- Last updated
- 3 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04652817
- Acronym / sponsor ID
- MD/MMI-22-04-2019
- Conditions
- Labia Majora Atrophy and Hypotrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Mesoestetic Pharma Group S.L.Industry (pharma, biotech, devices)
- Study start
- 11 Nov 2019 (actual)
- Primary completion
- 12 Jul 2020 (actual)
- Study completion
- 26 Aug 2020 (actual)
- First posted
- 3 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| MMI-22-04-2019 | Experimental | Device: MMI-22-04-2019Sodium 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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;
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MMI-22-04-2019A cross-linked form of the Hyaluronic Acid is used in intradermal injection to augment the labia majora area. | Device | MMI-22-04-2019 |
Primary outcome
Visual Analogous Scale (VAS) absolute change
Time frame: From Day 0 (Session 1) to Day 60 (Session 3) - up to 8 weeks.
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]
Time frame: From screening through study completion, an average of 90 days - daily.
Frequency and severity of adverse events (AEs) and adverse device effects.
3 secondary outcomes
Visual Analogous Scale (VAS)
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)
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
Time frame: Days 0 (immediately after application), 30, 60 and 90 (up to 4 weeks, 8 weeks and 12 weeks respectively).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MMI-22-04-2019 in people with Labia Majora Atrophy and Hypotrophy, run by Mesoestetic Pharma Group S.L. at 1 site in Bulgaria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bulgaria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogous Scale (VAS) absolute change (time frame: From Day 0 (Session 1) to Day 60 (Session 3) - up to 8 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2020; AzTrials last refreshed its copy on 8 Nov 2026.