Efficacy and Safety of High-Intensity, High-Frequency, Parallel Ultrasound Beams for the Treatment of Upper and Lower Facial Laxity: A Pilot Study
Phase 4
- Conditions
- Participants age 30-50 years, BMI less than 25 kg/m2, and have mild to moderate severity of upper and lower facial laxity using a comprehensive quantitative 4-point laxity grading scaleupper face, lower face, laxity, sofwave, ultrasound
- Registration Number
- TCTR20220507001
- Lead Sponsor
- Sofwave Medical Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- nknown
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
1. BMI < 25 kg/m2
2. Participants with mild to moderate severity of upper and lower facial laxity using a comprehensive quantitative 4-point laxity grading scale
Exclusion Criteria
1. Pregnant or lactating women
2. Having metals in the body or pacemakers or electronic medical devices
3. Severe acne or cystic acne on face
4. Taking oral isotretinoin or oral retinoids in the past 6 months
5. Other skin diseases or having infection at the area of face
6. Immunocompromised patients
7. Treated with botulinum toxin or laser treatment in the past 6 months
8. Treated with filler on face in the past 6 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Volume differences baseline, immediately after treatment, 1 month, 3 months, and 6 months Vectra H1
- Secondary Outcome Measures
Name Time Method Wrinkles and texture baseline, immediately after treatment, 1 month, 3 months, and 6 months Antera,Skin elasticity baseline, immediately after treatment, 1 month, 3 months, and 6 months Cutometer,Physician and patient assessment immediately after treatment, 1 month, 3 months, and 6 months 6-points scale,Safety immediately after treatment, 1 month, 3 months, and 6 months Side effects