Absorbable Micro-Aesthetic Lifting Thread for Nasolabial Fold Correction: A Multicenter, Randomized, Evaluator-Blinded, Parallel-Controlled Clinical Trial.

BACKGROUND: Absorbable lifting threads achieve lifting and support of facial soft tissues through subcutaneous implantation, eventually degrading naturally within the body. They are applied for the correction of nasolabial fold (NLF).
OBJECTIVES: This study evaluated the efficacy and safety of a novel absorbable micro-aesthetic lifting thread compared with a marketed polydioxanone thread for correcting moderate-to-severe NLF.
METHODS: A prospective, multicenter, randomized, evaluator-blinded, parallel-controlled design was utilized. A total of 151 subjects with a NLF severity of grade ≥ 3 on the Wrinkle Severity Rating Scale (WSRS) were enrolled and randomized to the experimental group or control group. The primary endpoint was the 7-month WSRS response rate (≥ 1 grade improvement). Secondary endpoints included short-term response rates, Global Aesthetic Improvement Scale (GAIS) scores, device handling performance, and safety indicators.
RESULTS: The 7-month response rate in the full analysis set was 71.6% for the experimental group and 62.7% for the control group. The difference was 8.95% (95% CI - 6.06-23.97%), confirming non-inferiority. The experimental group was significantly superior to the control group in the response rate at 3 months post-procedure, as well as in investigator satisfaction and barb fixation performance (P < 0.05). Both groups exhibited comparable safety profiles with no serious adverse events.
CONCLUSION: The clinical regimen combining the novel absorbable micro-aesthetic lifting thread with a multi-plane lifting strategy is effective and safe for NLF correction, demonstrating non-inferiority to the marketed comparator. It exhibits potential advantages in terms of investigator satisfaction and early aesthetic improvement, along with superior handling performance.
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