Trials / Completed
CompletedNCT07467811
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
Efficacy and Safety of a Monopolar Radiofrequency Device for the Improvement of Periorbital and Cheek Wrinkles: A Multicenter, Randomized, Single-Blind, Noninferiority Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 80 (actual)
- Sponsor
- TENTECH INC. · Industry
- Sex
- All
- Age
- 30 Years – 65 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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) |
Timeline
- Start date
- 2024-05-10
- Primary completion
- 2024-11-13
- Completion
- 2025-01-07
- First posted
- 2026-03-12
- Last updated
- 2026-03-12
Locations
3 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT07467811. Inclusion in this directory is not an endorsement.