Ignite Creation Date:
2024-07-17 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06486740
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2024-06-27
Brief Title:
Evaluation of the Safety and Performance Characteristics of Mesofiller Aox for the Correction of Mild and Moderate Facial Wrinkles
Sponsor:
Mesoestetic Pharma Group SL
Organization:
Mesoestetic Pharma Group SL
Study Overview
Official Title:
An Open-label Uncontrolled Single Centre Investigation for the Evaluation of the Safety and Performance Characteristics of the Dermal Filler of Hyaluronic Acid 20 mgml 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
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 sl 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None