Evaluation of the Efficacy and Safety of the Dermal Filler for Augmentation of Labia Majora.

NCT04652817 | Completed

• 1 other identifier: MD/MMI-22-04-2019
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Labia Majora Atrophy and Hypotrophy

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  From screening through study completion, an average of 90 days - daily.

Secondary Outcomes (3)

• Visual Analogous Scale (VAS)

  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)

  From Day 0 (immediately after application) to Days 30, 60 and 90 (up to 4 weeks, 8 weeks and 12 weeks respectively).

• Subject satisfaction

  Days 0 (immediately after application), 30, 60 and 90 (up to 4 weeks, 8 weeks and 12 weeks respectively).

Study Arms (1)

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.

Device: MMI-22-04-2019

Interventions

MMI-22-04-2019 DEVICE

A cross-linked form of the Hyaluronic Acid is used in intradermal injection to augment the labia majora area.

MMI-22-04-2019

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Gender-based pathology.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 with limited mental activity and consistent comprehension ability; sportsmen and individuals on strenuous physical loading; prisoners;
• Refusal to sign the Informed Consent Form.

Sponsors & Collaborators

• Mesoestetic Pharma Group S.L.: lead

Study Sites (1)

Medical Centre Ramus

Sofia, 1592, Bulgaria

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: February 20, 2020
• First Posted: December 3, 2020
• Study Start: November 11, 2019
• Primary Completion: July 12, 2020
• Study Completion: August 26, 2020
• Last Updated: December 3, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1)