Safety and Efficacy of XP200 Radiofrequency Treatment of Wrinkles

Not Applicable

Completed

• Conditions: Periorbital Wrinkles
• Interventions: Device: RF XP200; Device: XP200 RF device

• 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

Study Timeline

• Study Start: 2012-08
• Primary Completion: 2012-12
• Study First Submitted: 2013-02-18
• Study First Submitted QC: 2013-02-19
• Study First Posted: 2013-02-20
• Study Completion: 2013-03
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-06
• Last Update Posted: 2013-08-07

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

Arm && Interventions

Group	Intervention	Description
XP200 device RF treatments	RF XP200	Every subject in the study will undergo 4 treatments and will be followed up for 6 months with photoraphic 3 evaluations: before treatment, 3 and 6 months follow-up. Photographs will be scored on a Fitzpatrick scale by 3 blinded evaluators.
XP200 device RF treatments	XP200 RF device	Every subject in the study will undergo 4 treatments and will be followed up for 6 months with photoraphic 3 evaluations: before treatment, 3 and 6 months follow-up. Photographs will be scored on a Fitzpatrick scale by 3 blinded evaluators.

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