CompletedNot Applicable

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

South Korea80 participantsStarted 2024-05-10

Plain-language 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.

Who can participate

Age range30 Years – 65 Years

SexALL

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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

What they're measuring

CROW'S FEET GRADING SCALE (CFGS)

Timeframe: 16weeks

CHEEK Line GRADING SCALE (CLGS)

Timeframe: 16weeks

Trial details

NCT IDNCT07467811

SponsorTENTECH INC.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-11-13

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