WrinklesNCT07467811
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
A study testing 10THERMA and Thermage FLX in people with Wrinkles, run by TENTECH INC. at 3 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Wrinkles
- What is being tested?
- 10THERMA and Thermage FLX
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 10 May 2024to 7 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Chung-Ang University Gwangmyeong Hospital
Gwangmyeong, Deokan
Severance Hospital
Seoul, Seodaemungu, 03722
Asan Medical Center
Seoul, Songpagu
About this study
Official title: 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.
- Conditions
- Wrinkles
- Being tested
- 10THERMA, Thermage FLX
- Keywords
- periorbital and cheek wrinkles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10THERMADevice
10THERMA : Size of face tip is 5.0 cm2 (Treatment area)
Thermage FLXDevice
10THERMA : Size of face tip is 4.0 cm2 (Treatment area)
| Study group | Role | What they receive |
|---|---|---|
| 10THERMA group | Experimental | Treated by 10THERMA Receives: Device: 10THERMA |
| Thermage FLX group | Experimental | Treated by Thermage FLX Receives: Device: Thermage FLX |
What is being measured
The primary outcome is the main question the study is designed to answer.
CROW'S FEET GRADING SCALE (CFGS)
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.
Measured: 16weeks
CHEEK Line GRADING SCALE (CLGS)
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.
Measured: 16weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start10 May 2024
- Primary completion13 Nov 2024
- Study completion7 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WrinklesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- TENTECH INC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07467811
- Sponsor's protocol ID
- 1-2024-0014, 2024-0469, 2403-1
- Other IDs
- 1452
- Status last verified
- Mar 2026
- First submitted
- 10 Feb 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of a Monopolar Radiofrequency Device for the Improvement of Periorbital and Cheek Wrinkles: A Multicenter, Randomized, Single-Blind, Noninferiority Trial
- ClinicalTrials.gov ID
- NCT07467811
- Acronym / sponsor ID
- 1-2024-0014, 2024-0469, 2403-1
- Conditions
- Wrinkles
- Keywords
- periorbital and cheek wrinkles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- TENTECH INC.Industry (pharma, biotech, devices)
- Study start
- 10 May 2024 (actual)
- Primary completion
- 13 Nov 2024 (actual)
- Study completion
- 7 Jan 2025 (actual)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10THERMA group | Experimental | Device: 10THERMATreated by 10THERMA |
| Thermage FLX group | Experimental | Device: Thermage FLXTreated by Thermage FLX |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 10THERMA10THERMA : Size of face tip is 5.0 cm2 (Treatment area) | Device | 10THERMA group |
| Thermage FLX10THERMA : Size of face tip is 4.0 cm2 (Treatment area) | Device | Thermage FLX group |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 10THERMA and Thermage FLX in people with Wrinkles, run by TENTECH INC. at 3 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CROW'S FEET GRADING SCALE (CFGS) (time frame: 16weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.