NCT06477432

Evaluation of the Safety and Performance Characteristics of Mesofiller Mesotox for the Correction of Wrinkles and Rehydration of the Face.

An Open-label Uncontrolled Single Centre Investigation for the Evaluation of the Safety and Performance Characteristics of the Dermal Filler of Mesoestetic Mesofiller Mesotox for the Correction of Wrinkles and Rehydration of the Face. Clinical Investigation to Assess Safety and Performance of Mesofiller Mesotox.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (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 the evaluation of the safety and performance of the product mesofiller® mesotox 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 mesofiller® mesotox 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 provides a temporary filling of dermal tissue to correct small skin defects, such as wrinkles or scars in the upper part of the face, while also providing hydration to the face. mesofiller® mesotox is a sterile, injectable, gel colourless, transparent, non-pyrogenic, reabsorbable product 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 were 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 mesofiller® mesotox 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. Both sessions were conducted within 14-day intervals. The evaluation process during the medical examination was facilitated by photographic evidence taken before and after therapy at predetermined time points for reference.

Conditions

• Skin Aging
• Skin Wrinkling

Interventions

Type	Name	Description
DEVICE	mesofiller® mesotox	The investigated product mesofiller® mesotox 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. Both sessions were conducted within 14-day intervals.

Timeline

• Start date: 2022-11-15
• Primary completion: 2023-07-05
• Completion: 2023-07-05
• First posted: 2024-06-27
• Last updated: 2024-06-27

Locations

1 site across 1 country: Bulgaria