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 scale upper face, lower face, laxity, sofwave, ultrasound
Conditions
Interventions
All participants were treated with Sofwave from cheeks (first) to forehead (last).
Experimental Device
high-intensity, high-frequency, parallel ultrasound beams
Sponsors
Sofwave Medical Ltd.
Eligibility
Sex/Gender
All
Age
30 Years to 50 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Volume differences baseline, immediately after treatment, 1 month, 3 months, and 6 months Vectra H1 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Thailand
Contacts
Public ContactRungsima Wanitphakdeedecha
Faculty of Medicine Siriraj Hospital, Mahidol University
Outcome results
None listed