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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

NCT07467811 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-03-12

No results posted yet for this study

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.

Conditions

  • Wrinkles

Interventions

DEVICE

10THERMA

10THERMA : Size of face tip is 5.0 cm2 (Treatment area)

DEVICE

Thermage FLX

10THERMA : Size of face tip is 4.0 cm2 (Treatment area)

Sponsors & Collaborators

  • TENTECH INC.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-10
Primary Completion
2024-11-13
Completion
2025-01-07

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07467811 on ClinicalTrials.gov