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Efficacy and Safety of using microfocused ultrasound with circular cartridge for upper face laxity in Thailand

Phase 4
Recruiting
Conditions
pper facial laxity
micro-focused ultrasound
laxity
brow lifting
Registration Number
TCTR20230418001
Lead Sponsor
Faculty of Medicine Siriraj Hospital, Mahidol University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
37
Inclusion Criteria

1. A person who has mild to moderate sagging of the face that wants to lift the eyebrows.
2. Being a Thai person of Asian descent
3. Volunteers who voluntarily agree to participate in the project

Exclusion Criteria

1. Pregnant women and breastfeeding women.
2. Had dermatitis, wounds, or skin infections on the face.
3. Subjects who had undergone thread lifting or face lifting devices or had facial surgery within 12 months of participating in the study.
4. Subjects with a history of receiving filler or botulinum toxin injections within 6 months before study participation.
5. Volunteers with uncontrolled heart disease, uncontrolled thyroid disease, autoimmune disease, taking immunosuppressant drugs, using a pacemaker, and having metal implants on the face.
6. Subjects have a history of hypertrophic scars or keloids.
7. Subjects with mental disorders whom a psychiatrist has diagnosed.
8. Subjects who are not allowed to take pictures for treatment evaluation
9. Subjects with excessive subcutaneous fat (ptotic fat)
10. Subjects taking NSAIDs, ASA, and steroids in the 72 hours before treatment
11. Subjects with a history of allergies to both injectable and topical anesthetics

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Degree of wrinkles Before treatment, 2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks after treatment Antera 3D analysis,Eyebrow height Before treatment, 2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks after treatment Measuring from pictures using ImageJ software
Secondary Outcome Measures
NameTimeMethod
Adverse events 2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks after treatment Clinical evaluation
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