Safety and Efficacy of XP200 Radiofrequency Treatment of Wrinkles

BTL Industries Ltd.50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Periorbital Wrinkles

Interventions

RF XP200DEVICE

Four weekly non-invasive periorbital wrinkles treatment with RF XP200 device

XP200 RF deviceDEVICE

4 RF treatments of periorbital region on one side of the face

Eligibility

Sex: ALLMin age: 35 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 35-60 years old * periorbital wrinkles Exclusion Criteria:

Outcomes

Primary Outcomes

Improvement in wrinkles appearance

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

Time frame: 3 months

Data from ClinicalTrials.gov

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