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

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.

Study Overview

• Status: Completed
• Conditions: Labia Majora Atrophy and Hypotrophy
• Intervention / Treatment: Device: MMI-22-04-2019

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 Type: Interventional
• Enrollment (Actual): 35
• 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 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MMI-22-04-2019; 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; A cross-linked form of the Hyaluronic Acid is used in intradermal injection to augment the labia majora area.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Days 0 (immediately after application), 30, 60 and 90 (up to 4 weeks, 8 weeks and 12 weeks 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): July 12, 2020
• Study Completion (Actual): August 26, 2020

Study Registration Dates

• First Submitted: February 20, 2020
• First Submitted That Met QC Criteria: December 2, 2020
• First Posted (Actual): December 3, 2020

Study Record Updates

• Last Update Posted (Actual): December 3, 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: Pathological Conditions, Anatomical; Atrophy
• Other Study ID Numbers: MD/MMI-22-04-2019

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