Ignite Creation Date:
2025-12-24 @ 11:45 AM
Ignite Modification Date:
2025-12-29 @ 6:15 AM
Study NCT ID:
NCT03776461
Status:
COMPLETED
Last Update Posted:
2023-08-15
First Post:
2018-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Fractional Radiofrequency for the Treatment and Reduction of Facial Wrinkles
Sponsor:
Venus Concept
Organization:
Study Overview
Official Title:
Clinical Evaluation of the Safety and Performance of Fractional Radiofrequency for the Treatment and Reduction of Facial Wrinkles
Status:
COMPLETED
Status Verified Date:
2023-08
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:
Prospective, single centre, evaluator-blind study of the safety and performance of fractional radiofrequency (RF) for the treatment and reduction of facial wrinkles.
Detailed Description:
The study will evaluate 50 treatment sites in subjects requesting treatment of their facial wrinkles. The study will involve three treatments on both sides of the face with 3-5 week intervals between each treatment. Subjects will be followed at 6 and 12 weeks after their last treatment. Analysis will be performed on all subjects who receive at least one treatment
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: