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

Zhejiang University

Status: Active, not recruiting

Conditions: Middle and Lower Face and Submental Region Skin Laxity

Treatments: Procedure: HIFU

Study type: Interventional

Funder types: Other

Identifiers

NCT06449911

2022-0919

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 30 to 59 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: healthy male or female, aged 30-60 years, seeking improved jawline definition, and/or reduction of submental skin laxity and were willing and able to provide informed consent.

Exclusion Criteria: Pregnancy or lactation, severe sun damage, excessive skin laxity on the lower face and neck, keloid scarring or open wounds in the treatment areas, severe or cystic facial acne, history of cosmetic treatments in the area to be treated (skin tightening procedure within the past year; injectable filler or botox within the past 6 months; ablative or nonablative resurfacing/rejuvenating laser treatment or light treatment within the past 6 months; dermabrasion or deep facial peels within the past 6 months), isotretinoin treatment within the past 6 months, and inability to understand the treatment protocol or to give informed consent.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

HIFU

Experimental group

Description:

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.

Treatment:

Procedure: HIFU