Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 11:37 AM
Study NCT ID:
NCT07381218
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-03-03
First Post:
2026-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Focused Ultrasound Treatment for Facial Skin Laxity
Sponsor:
The Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Organization:
Study Overview
Official Title:
A Prospective, Randomized, and Split-Face Study to Evaluate the Efficacy and Safety of Focused Ultrasound for Facial Skin Laxity
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2026-02
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 goal of this clinical trial is to learn if focused ultrasound can improve facial skin laxity in adults. The main questions this study aims to answer are:
1. Does focused ultrasound treatment lead to clinically meaningful improvement in facial skin laxity compared with baseline assessments?
2. What treatment-related adverse events occur following focused ultrasound treatment, and how frequently and severely do they occur? Researchers will also compare outcomes between the two sides of the face treated with different focused ultrasound hand-pieces within the same participants to explore potential differences in clinical response and safety using a randomized split-face design.
Participants will:
Receive a single session of focused ultrasound treatment applied to both sides of the face.
Undergo standardized clinical assessments, imaging evaluations, and patient-reported outcome measures at baseline and during follow-up visits.
Be monitored for treatment-related adverse events throughout the study period.
1. Does focused ultrasound treatment lead to clinically meaningful improvement in facial skin laxity compared with baseline assessments?
2. What treatment-related adverse events occur following focused ultrasound treatment, and how frequently and severely do they occur? Researchers will also compare outcomes between the two sides of the face treated with different focused ultrasound hand-pieces within the same participants to explore potential differences in clinical response and safety using a randomized split-face design.
Participants will:
Receive a single session of focused ultrasound treatment applied to both sides of the face.
Undergo standardized clinical assessments, imaging evaluations, and patient-reported outcome measures at baseline and during follow-up visits.
Be monitored for treatment-related adverse events throughout the study period.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: