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Efficacy and Safety of using microfocused ultrasound with circular cartridge for enlarged pores in Thailand

Phase 4
Recruiting
Conditions
Enlarged pores
micro-focused ultrasound
circular cartridge
Registration Number
TCTR20230417003
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
32
Inclusion Criteria

1. A person with visibly enlarged pores on both cheeks that can be seen at a distance of 50 centimeters.
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
Pore volume Before treatment, 2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks after treatment Antera 3D analysis
Secondary Outcome Measures
NameTimeMethod
Adverse events 2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks after treatment clinical evaluation
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