Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2026-04-08 @ 5:04 PM
Study NCT ID:
NCT02444169
Status:
COMPLETED
Last Update Posted:
2017-11-24
First Post:
2015-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retrospective Evaluation of Combination Treatment With the Ulthera System
Sponsor:
Ulthera, Inc
Organization:
Study Overview
Official Title:
Retrospective Evaluation of Safety of Combination Treatment With the Ulthera® System and Xeomin, Belotero Balance, and Radiesse
Status:
COMPLETED
Status Verified Date:
2015-08
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:
A retrospective study to evaluate the Ulthera® System for its potential interaction with toxins and fillers. Up to 500 subjects will be enrolled.
Detailed Description:
This is a retrospective, multi-site study involving chart reviews of subjects who have received an Ultherapy treatment along with Radiesse®, Xeomin®, and/or Belotero® Balance within six months apart in the face and/or neck areas. Enrolled subjects will have received an Ultherapy treatment along with botulinum toxin A and/or filler treatment(s) within the last two years and with filler and toxin treatment occurring within 6 months before or after Ultherapy.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: