NCT06486740

Evaluation of the Safety and Performance Characteristics of Mesofiller Aox for the Correction of Mild and Moderate Facial Wrinkles.

An Open-label Uncontrolled Single Centre Investigation for the Evaluation of the Safety and Performance Characteristics of the Dermal Filler, of Hyaluronic Acid 20 mg/ml, (M-AOX-2021) for Soft Tissue Augmentation Intended to be Used as a Temporary Dermal Filler for the Correction of Mild and Moderate Facial Wrinkles.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Mesoestetic Pharma Group S.L. · Industry
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The investigation is a single centre, interventional, prospective, non-randomized, open-label, uncontrolled, single arm, un-blinded investigation for evaluation of safety and performance of the medical device M-AOX-2021 in the treatment of wrinkles and imperfections. The clinical investigation is interventional and prospective in agreement with the pre-market regulatory status of the product.

Detailed description

The product M-AOX-2021 is a dermal filler manufactured by mesoestetic Pharma Group s.l.. It was intended to be used as a temporary dermal filler for dermatological treatment for aesthetic purposes. The product corrects wrinkles and imperfections of the lower two thirds of the face, while also providing hydration and an antioxidant action to the skin. Мesofiller aox for facial area is a sterile, injectable, gel colourless, transparent, non-pyrogenic, reabsorbable medical device made out of cross-linked hyaluronic acid of non-animal origin, produced via bacterial fermentation. This clinical investigation was conducted as an uncontrolled - no comparator medical device or other product was used. The safety and performance of the treatment was evaluated by comparison of the condition with the state of the treated area before initiation of the procedure, conducted by the trained Principal Investigator. The investigated product M-AOX-2021 was applied by intradermal or subcutaneous injection by the investigator during Session 1 for all subjects and Session 2 for the subjects, for whom a touch-up was considered beneficial. The both sessions was conducted within 14 days interval. The process of the evaluation during the medical examination was facilitated by photographic evidence taken before and after therapy at a predetermined time points for reference.

Conditions

• Skin Aging
• Skin Wrinkling

Interventions

Type	Name	Description
DEVICE	mesofiller aox	The investigated product M-AOX-2021 was applied by intradermal or subcutaneous injection by the investigator during Session 1 for all subjects and Session 2 for the subjects, for whom a touch-up was considered beneficial. The both sessions was conducted within 14 days interval.

Timeline

• Start date: 2022-10-03
• Primary completion: 2024-01-08
• Completion: 2024-01-08
• First posted: 2024-07-03
• Last updated: 2024-07-03

Locations

1 site across 1 country: Bulgaria