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Safety and Efficacy of XP200 Radiofrequency Treatment of Wrinkles

NCT ID: NCT01795417

Last Updated: 2013-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2013-03-31

Brief Summary

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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

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Conditions

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Periorbital Wrinkles

Keywords

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wrinkles rhytids periorbital

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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XP200 device RF treatments

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.

Group Type EXPERIMENTAL

RF XP200

Intervention Type DEVICE

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

XP200 RF device

Intervention Type DEVICE

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

Interventions

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RF XP200

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

Intervention Type DEVICE

XP200 RF device

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 35-60 years old
* periorbital wrinkles
Minimum Eligible Age

35 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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BTL Industries Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Georgi Petkov

Role: STUDY_DIRECTOR

BTL Industries Ltd.

Other Identifiers

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XP200 3.25 MHZ RF

Identifier Type: -

Identifier Source: org_study_id