Healthy absorbable mesh suture, polydioxanone, effectiveness, safety
Conditions
Interventions
Volunteers were treated lower face laxity with Tesslift Soft for 1 time. Follow-up effectiveness (image, Vector H1r, 6-points scale) and safety (side effects, pain using visual analog scale) at 2 week
Experimental Device
Tesslift Soft (Absorbable Polydioxanone Suture)
Sponsors
Edencolors (Thailand) Co., Ltd.
Eligibility
Sex/Gender
All
Age
30 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Thai healthy volunteers aged 30-55 years 2. Body mass index < 30 kg/m2 3. Patients with mild to moderate facial laxity 4. No underlying disease, not taking anti-inflammatory drug, antiplatelet drug, vitamin C, or vitamin E
Exclusion criteria
Exclusion criteria: 1. Patients who are pregnant, lactating, and postpartum within 3 months 2. Patients with history of polydioxanone, xylocaine, and adrenaline allergy 3. Patients with other skin diseases, or having infection at the area of face 4. Immunocompromised patients 5. Patients with hypertrophic scar or keloid 6. Patients with history of regular smoking 7. Patients treated with botulinum toxin or laser on the face in the past 6 months 8. Patients treated with filler or mesh suture on the face in the past 12 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Face volume Baseline, 2 weeks, 1, 2, 3, 6, and 12 months after treatment VECTRA3D analysis,Physician improvement scale Baseline, 2 weeks, 1, 2, 3, 6, and 12 months after treatment 6 points scale,Patient improvement scale Baseline, 2 weeks, 1, 2, 3, 6, and 12 months after treatment 6 points scale | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Baseline, 2 weeks, 1, 2, 3, 6, and 12 months after treatment Adverse event | — |
Countries
Thailand
Contacts
Public ContactRungsima Wanitphakdeedecha
Faculty of Medicine Siriraj Hospital, Mahidol University
Outcome results
None listed