Tokyo, Oct. 5 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063172) titled 'Comparing Two Minimally Invasive Thread-Lifting Treatments for Moderate-to-Severe Nasolabial Folds' on Oct. 4.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -but assessor(s) are blinded Control - Active

Primary Sponsor: Institute - Beijing Tsinghua Changgung Hospital

Condition: Condition - Moderate-to-severe nasolabial folds Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To compare the efficacy and safety of two minimally invasive thread-lifting protocols for correction of moderate-to-severe nasolabial folds. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Experimental intervention: predominantly multi-plane tissue-repositioning and lifting thread-lifting protocol, including malar fat pad lifting, temporal lifting, zygomatic lifting, and local nasolabial fold support with absorbable threads. Interventions/Control_2 - Active comparator: predominantly multiregional tissue-support and volumization thread-lifting protocol, including nasolabial fold support, infraorbital and paranasal support, and infraorbital/paranasal lifting with absorbable threads.

Eligibility: Age-lower limit - 18 years-old = Gender - Male and Female Key inclusion criteria - 1. Healthy Chinese men or women aged 18 to 65 years. 2. Bilateral nasolabial fold wrinkles with a severity grade >= 3 on the Wrinkle Severity Rating Scale (WSRS). 3. Willing to undergo thread lifting for correction of nasolabial folds. 4. Willing to participate in the study and able to provide written informed consent. Key exclusion criteria - 1.With a hypersensitive constitution. 2.With tendency to develop hypertrophic or keloid scars. 3.With known history of bleeding disorders. 4.With inflammation or infectious cutaneous disorders in or near the studied zones (herpes, acne, mycosis, papilloma). 5.With psychological disorders or psychiatric illnesses. 6.Under laser therapy or chemical peeling in the treatment area within 6 months, or injection of botulinum toxin type A within 6 months. 7.Injection of non-permanent fillers (e.g., hyaluronic acid, collagen) in the treatment area within 1 year. 8.Prior facial implantation of permanent fillers. 9.Use of anticoagulant or antiplatelet medications within 2 weeks prior to surgery. 10.Women who were pregnant, planning pregnancy, or breastfeeding. 11.Other conditions deemed unsuitable for participation in the clinical trial by the investigator. Target Size - 180

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2023 Year 08 Month 01 Day Date of IRB - 2023 Year 10 Month 19 Day Anticipated trial start date - 2023 Year 11 Month 01 Day Last follow-up date - 2024 Year 06 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072296

Disclaimer: Curated by HT Syndication.