Effectiveness and safety of absorbable mesh suture for treatment of lower face laxity

Phase 4

Recruiting

• Conditions: Healthy; absorbable mesh suture, polydioxanone, effectiveness, safety

• Registration Number: TCTR20210520003
• Lead Sponsor: Edencolors (Thailand) Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-20
• Study Completion: 2022-08-12
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Safety Baseline, 2 weeks, 1, 2, 3, 6, and 12 months after treatment Adverse event