The Efficacy of Microfocused Ultrasound Technique in the Treatment of Facial Skin Laxity

NCT06449911 | Unknown

• 1 other identifier: 2022-0919
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective study of 20 Chinese patients with lower facial laxity treated by High Intense focused ultrasound (HIFU). Response will be assessed via paired comparison of pretreatment and posttreatment photographs by two independent dermatologists, grading on a 5-point Subject Global Aesthetic Improvement Scale (SGAIS) for skin laxity. Quantitative analysis of submental lifting will also be performed. Patient's level of "sagging" and "volume loss", satisfaction and tolerance will be documented.

Conditions

Middle and Lower Face and Submental Region Skin Laxity

Outcome Measures

Primary Outcomes (1)

• 5-point Subject Global Aesthetic Improvement Scale (SGAIS) for skin laxity

  0-worse, 1-0%-25% poor response, 2-25%-50% fair response, 3-50%-75% good response, 4-75%-100%-excellent response.

  6 months after HIFU treatment

Study Arms (1)

HIFU

EXPERIMENTAL

All participants will be treated using M4.5, level V, with 150 lines on the lower face and submental area; D4.5, level V, 10 Hz, with 4200 dots performed in 7 min on the lower face and the perioral and preauricular areas; M3.0, level V, with 150 lines on the lower face and submental area; D3.0, level V, 10 Hz, with 6000 dots performed in 10 min on the lower face, submental area, and middle face. The microfocused probes were uniformly set to a length of 25 mm with an interval of 1.5 mm. A total of 300 lines and 10,200 dots were performed for each half lower two-thirds of the face and submental area.

Procedure: HIFU

Interventions

HIFU PROCEDURE

300 lines and 10,200 dots will be performed to each half lower two-thirds of the face and submental area of every participant.

HIFU

Eligibility Criteria

• Age: 30 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Department of Dermatology, Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 10, 2024
• Study Start: February 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: June 10, 2024

Record last verified: 2023-12

Locations

CN (1)