An interventional study of HIFU in Middle and Lower Face and Submental Region Skin Laxity, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Active, not recruiting at 1 site in China. Open to participants aged 30 Years to 59 Years. Per ClinicalTrials.gov, last updated 2024-06-10.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Not applicable, Interventional, and Treatment
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.
147 studies on the registry are indexed under Cutis Laxa; 35 are open to participants now.
This study's enrollment of 20 is below the median of 30 across 129 interventional studies indexed under Cutis Laxa.
Browse Cutis Laxa studies →Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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
300 lines and 10,200 dots will be performed to each half lower two-thirds of the face and submental area of every participant.
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.
Time frame: 6 months after HIFU treatment
This study is active, not recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Second Affiliated Hospital, School of Medicine, Zhejiang University