Absorbable Barbed Threads for Lower Facial Soft Tissue Repositioning in Asians

Phase 4

Completed

• Conditions: Absorbable Barbed Threads for Lower Facial Lifting; absorbable barbed threads, lower face lifting facial rejuvenation

• Registration Number: TCTR20210415001
• Lead Sponsor: Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand

Brief Summary

Absorbable barbed threads implantation is a safe and effective treatment for facial rejuvenation in Thai patients. Long threads (23-cm) showed a slight superiority in face lifting efficacy, which suggests the benefit of additional barbs in tissue suspension and biostimulation.

Detailed Description

Not available

Study Timeline

• Study Completion: 2020-12-25
• Study Start: 2021-04-15
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 27

Inclusion Criteria

Male and female, between 30-55 years of age, with a maximum body mass index of 30 kg/m2 and mild to moderate facial laxity (1.5-2.5 points, according to a 4-point Quantitative Grading Scale for laxity),27 were included

Exclusion Criteria

patients who were pregnant or lactating; with a history of keloid or hypertrophic scar formation; a history of botulinum toxin, mesotherapy or laser treatment in the last 6 months; a history of filler injection in the last 12 months; concurrent dermatological disease, autoimmune disease or infection in the targeted area; currently using medications including antibiotics, anticoagulants, vitamin C or E supplementation, steroids, or nonsteroidal anti-inflammatory drugs (NSAID). Other exclusion criteria were a history of allergy to p(LA-CL), local anesthesia or adrenaline; a history of smoking; and patients who may not cooperate or comply with medical treatment requirements.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
clinical improvement of facial laxity at 1-week, 1,2,3,6,12-month after end of the intervention graded by two blinded dermatologists

Secondary Outcome Measures

Name	Time	Method
volume in the jawline, nasolabial folds and submental area at 1-week, 1,2,3,6,12-month after end of the intervention Vectra H1 Imaging System,Patient self-assessment at 1-week, 1,2,3,6,12-month after end of the intervention Patient self-assessment scores,adverse reactions at 1-week, 1,2,3,6,12-month after end of the intervention observed by dermatologists