NCT04652817

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Mesoestetic Pharma Group S.L. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Labia Majora Atrophy and Hypotrophy

Interventions

Type	Name	Description
DEVICE	MMI-22-04-2019	A cross-linked form of the Hyaluronic Acid is used in intradermal injection to augment the labia majora area.

Timeline

• Start date: 2019-11-11
• Primary completion: 2020-07-12
• Completion: 2020-08-26
• First posted: 2020-12-03
• Last updated: 2020-12-03

Locations

1 site across 1 country: Bulgaria