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

March 11, 2026 updated by: TENTECH INC.

Efficacy and Safety of a Monopolar Radiofrequency Device for the Improvement of Periorbital and Cheek Wrinkles: A Multicenter, Randomized, Single-Blind, Noninferiority Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
    • Deokan
      • Gwangmyeong, Deokan, South Korea
        • Chung-Ang University Gwangmyeong Hospital
    • Seodaemungu
      • Seoul, Seodaemungu, South Korea, 03722
        • Severance Hospital
    • Songpagu
      • Seoul, Songpagu, South Korea
        • Asan Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Crow's Feet Grading Scale (CFGS) score of 1-2 at rest (neutral facial expression) for periorbital wrinkles and a Cheek Line Grading Scale (CLGS) score of 1-2 for cheek wrinkles

Exclusion Criteria:

  • recent cosmetic procedures, facial malignancy or prior radiotherapy, active dermatologic disease at the treatment site, keloid or abnormal wound healing tendency, immunosuppression, and pregnancy or lactation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 10THERMA group
Treated by 10THERMA
Device: 10THERMA
10THERMA : Size of face tip is 5.0 cm2 (Treatment area)
Experimental: Thermage FLX group
Treated by Thermage FLX
Device: Thermage FLX
10THERMA : Size of face tip is 4.0 cm2 (Treatment area)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CROW'S FEET GRADING SCALE (CFGS)
Time Frame: 16weeks
CROW'S FEET GRADING SCALE (CFGS) To assess wrinkle improvement in each area around the eyes, the CFGS will be administered at baseline, at Week 4, and at Week 16. At baseline, the CFGS will be administered prior to application of the investigational device. Each wrinkle scale will be assessed by the investigator and an independent evaluator, who will use photographs of the area where the investigational device was applied taken at each time point, excluding screening. In the case of evaluation by the examiner, photographs are not used and evaluation is made through direct observation during the examination. The resting (neutral expression) CROW'S FEET GRADING SCALE (CFGS) score according to the degree of wrinkles is composed of 0 points (Absent : no wrinkles), 1 point (Mild : very fine wrinkles), 2 points (Moderate : fine wrinkles), 3 points (Severe : moderate wrinkles), and 4 points (Extreme : severe wrinkles), with a lower score indicating the absence of wrinkles.
16weeks
CHEEK Line GRADING SCALE (CLGS)
Time Frame: 16weeks
The Cheek Line Grading Scale (CLGS) will be administered at screening, baseline, weeks 4, and 16 to assess wrinkle improvement in each cheek area. The baseline assessment will be conducted prior to application of the clinical trial device. Each wrinkle scale will be assessed by the investigator and an independent evaluator, who will use photographs of the clinical trial device application site taken at each time point, excluding screening. In the case of evaluation by the examiner, photographs are not used, and evaluation is made through direct observation during the examination. The Cheek Line Grading Scale (CLGS) according to wrinkle severity is composed of 0 points (no wrinkles), 1 point (Minimal : 1~2 superficial lines), 2 points (Moderate : 3~5 superficial lines), 3 points (Severe : Greater than 5 superficial lines; no crosshatching), 4 points (Diffuse : Diffuse superficial lines; crosshatching), with a lower score indicating an absence of wrinkles.
16weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TENTECH INC.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2024

Primary Completion (Actual)

November 13, 2024

Study Completion (Actual)

January 7, 2025

Study Registration Dates

First Submitted

February 10, 2026

First Submitted That Met QC Criteria

March 11, 2026

First Posted (Actual)

March 12, 2026

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1-2024-0014, 2024-0469, 2403-1
  • 1452 (Other Identifier: Ministry of Food and Drug Safety)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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