Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06451822
Status:
COMPLETED
Last Update Posted:
2024-06-11
First Post:
2024-05-29
Brief Title:
Efficacy and Performance Evaluation of mIntense LAS 25 mgml Hyaluronic Acid for the Correction of Moderate to Deep Wrinkles and Folds
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 mIntense LAS Hyaluronic Acid 25 mgml M-INT-LS for Soft Tissue Augmentation to Correction of Moderate to Deep Wrinkles and Folds
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:
M-INT-LS
Brief Summary:
The investigation is a single-centre interventional prospective non-randomized open-label uncontrolled single-arm un-blinded investigation for evaluation of the safety and performance of the product mIntense LAS in the treatment of small skin defects such as wrinkles or scars The clinical investigation is interventional and prospective in agreement with the pre-market regulatory status of the product
Detailed Description:
The product mIntense LAS is a dermal filler manufactured by mesoestetic Pharma Group sl It was intended to be used as a temporary filler to correct small skin defects such as wrinkles or scars In particular it was recommended for the treatment of deep wrinkles
mIntense LAS for the facial area is a sterile injectable gel colourless transparent non-pyrogenic reabsorbable product containing cross-linked hyaluronic acid of non-animal origin produced via bacterial fermentation
This clinical investigation was conducted as an uncontrolled - no comparator 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 mIntense LAS 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
mIntense LAS for the facial area is a sterile injectable gel colourless transparent non-pyrogenic reabsorbable product containing cross-linked hyaluronic acid of non-animal origin produced via bacterial fermentation
This clinical investigation was conducted as an uncontrolled - no comparator 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 mIntense LAS 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
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