Clinical Trial

Single-Blind, Investigational Device Exemption Paired-Design, Non-Inferiority Trial With Confirmation for the Assessment of the Efficacy and Safety of a Universal Electrosurgical Device for Temporary Improvement of Mild and Moderate Wrinkles Around Both Eye Corners and Both Cheek Folds

Completed
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Summary
Radiofrequency (RF) devices are commonly used for noninvasive facial rejuvenation. This study compared the efficacy and safety of 10THERMA, a newly developed monopolar RF device, with those of the Thermage FLX system. To determine whether 10THERMA is noninferior to Thermage FLX in improving mild-to-moderate periorbital and cheek wrinkles.
Trial Details
NCT Number NCT07467811
Lead Sponsor TENTECH INC.
Conditions Wrinkles
Enrollment 80 participants
Start Date 2024-05-10
Primary Completion 2024-11-13 (estimated)
Study Completion 2025-01-07 (estimated)
Updated on ClinicalTrials.gov 2026-03-12