Safety and Efficacy of XP200 Radiofrequency Treatment of Wrinkles
Not Applicable
Completed
- Conditions
- Periorbital Wrinkles
- Registration Number
- NCT01795417
- Lead Sponsor
- BTL Industries Ltd.
- Brief Summary
To evaluate the wrinkle-reducing effects of 3.25-MHz radiofrequency (RF) energy delivered in 4 weekly applications to human periorbital skin area by grating pre- and 90-days post treatment photographs on the Fitzpatrick Wrinkle Severity Scale (FWSS) by three blinded evaluators.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
- 35-60 years old
- periorbital wrinkles
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Improvement in wrinkles appearance 3 months One point or greater improvement in periorbital wrinkle score on a Fitzpatrick scale 3 months after last treatment as determined by at least 2 out of 3 blinded photographs evaluators
- Secondary Outcome Measures
Name Time Method