Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-28 @ 4:26 AM
Study NCT ID:
NCT05388604
Status:
COMPLETED
Last Update Posted:
2023-10-18
First Post:
2022-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study To Evaluate Paired Treatment With An Alexandrite Laser And Radiofrequency Microneedling For Facial Aging
Sponsor:
Cynosure, Inc.
Organization:
Study Overview
Official Title:
Prospective Clinical Study To Evaluate The Efficacy And Safety Of Paired Treatment With A Picosecond 755nm Alexandrite Laser With Focused Lens Array And Radiofrequency Microneedling For Facial Aging
Status:
COMPLETED
Status Verified Date:
2023-10
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 intended use of the radiofrequency and microneedling devices used in this study is to assess the efficacy and safety of paired treatment for the treatment of facial aging.
Detailed Description:
Subjects are to be enrolled in this clinical study if they are a healthy male or female 40 - 65 years of age. Up to 35 subjects will be enrolled at 2 study centers. Subjects will attend a screening/pretreatment visit which may be performed on the same day as the treatment visit. Subjects may receive up to 4 treatments on the face.
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?: