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

Labia Majora Atrophy and Hypotrophy Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04652817
• Other study ID #: MD/MMI-22-04-2019
• Status: Completed
• Phase: N/A
• Start date: November 11, 2019
• Est. completion date: August 26, 2020

Study information

• Verified date: December 2020
• Source: Mesoestetic Pharma Group S.L.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: August 26, 2020
• Est. primary completion date: July 12, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 370?;

• 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.

Related Conditions & MeSH terms

• Atrophy
• Labia Majora Atrophy and Hypotrophy

Intervention

Device:
• MMI-22-04-2019
A cross-linked form of the Hyaluronic Acid is used in intradermal injection to augment the labia majora area.

Locations

Country	Name	City	State
Bulgaria	Medical Centre Ramus	Sofia

Sponsors (1)

Lead Sponsor	Collaborator
Mesoestetic Pharma Group S.L.

Country where clinical trial is conducted

Bulgaria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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).
Secondary	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).
Secondary	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).