Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2026-01-05 @ 12:40 AM
Study NCT ID:
NCT04606368
Status:
COMPLETED
Last Update Posted:
2021-09-29
First Post:
2020-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bausch Health Thermage FXL for Use on Lower Face and Submentum Area
Sponsor:
Lorraine Hickson
Organization:
Study Overview
Official Title:
Evaluation of the Safety and Efficacy of Sequential Use of Monopolar Radiofrequency Treatment on Lower Face and Submental Area for Fat Reduction and Improvement of Skin Laxity
Status:
COMPLETED
Status Verified Date:
2021-09
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:
This study is designed to evaluate the safety and efficacy of sequential use of monopolar radiofrequency on lower face and submental area, followed by cryolipolysis on the submentum and submandibular area for fat reduction and improvement of skin laxity.
Detailed Description:
This research study will study subjects who have mild to moderate skin laxity on lower jaw and submentum areas. This will be measured by conducting a treatment using the Thermage FLX system on the lower face and submentum area of the participants. Biopsies will be done on several locations throughout the 12 week trial to assess skin laxity through laboratory measures. Finally, the subject will be asked to complete questionnaires to provide satisfaction and tolerability feedback.
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?:
False
Is an FDA AA801 Violation?: