An Exploratory Study to Evaluate the Safety of the High-Intensity Focused Ultrasound(HIFU) in Patients with sagging

JRCT ID: jRCTs032230634

Registered date:15/02/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Facial sagging
• Date of first enrollment: 15/02/2024
• Target sample size: 10
• Study type: Interventional
• Intervention(s): HIFU is applied to patients with facial sagging followed by evaluated with the efficacy using CT

Outcome(s)

Primary Outcome

Rate of the following adverse events
1)Pain that lasts for more than a week
2)Numbness or sensory disturbance that lasts for more than a week
3)Blistering, Burns

Secondary Outcome

1.The change in CT values from the baseline to the final evaluation of tissue ranging from the deep dermis to the superficial musculoaponeurotic system (SMAS)
2.The correlation between the facial contour calculated from photographs and the facial contour from CT images
3.The change in distance from the superficial layer of the skin to the superficial musculoaponeurotic system (SMAS) at the treatment site in CT images
4.Skin viscoelasticity measurement at pre-treatment and 4, 8, and 12 weeks post-treatment using a cutometer
5.Correlation of irradiation depth of HIFU with the following adverse events
1)Pain that lasts for more than a week
2)Numbness or sensory disturbance that lasts for more than a week
3)Blistering, Burns
6.Incidence rate of adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 30age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.Men and women 30 years of age or older at the time of obtaining consent.
2.Outpatient
3.Those who wish to improve facial contour and/or sagging around the eyelids by the treatment using HIFU
4.Subjects who have received a explanation of their participation in this study, and who have given written consent of their own free will based on sufficient understanding
5.Persons who are judged by the principal investigator to be capable of adequately evaluating the efficacy and safety of this study

Exclude criteria

1.Those who using a pacemaker and/or implantable cardiovascular-defibrillator (ICD)
2.Pregnant women, lactating women, and women who may be currently pregnant
3.Those with impaired wound healing, such as diabetes mellitus
4.Atopic dermatitis
5.Sunburned within 2 weeks
6.Keloid constitution
7.Those who previously underwent any aesthetic procedures including thread lift and injectable filler within one month prior to the intervention
8.Those who plan to undergo other aesthetic procedures during the study period.
9.Those who exhibit progressive sagging face due to aging
10.Other subjects who are deemed inappropriate as research subjects by the principal investigator.

Related Information

• Primary Sponsor: Mizuno Hiroshi