Safety and Efficacy of XP200 Radiofrequency Treatment of Wrinkles

August 6, 2013 updated by: BTL Industries Ltd.

Safety and Efficacy of Non-invasive Dermatologic Procedure With XP200 Radiofrequency for the Primary Treatment of Wrinkles and Rhytids

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 35-60 years old
  • periorbital wrinkles

Exclusion Criteria:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: RF XP200
Four weekly non-invasive periorbital wrinkles treatment with RF XP200 device
Device: XP200 RF device
4 RF treatments of periorbital region on one side of the face

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in wrinkles appearance
Time Frame: 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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BTL Industries Ltd.

Investigators

  • Study Director: Georgi Petkov, BTL Industries Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

February 18, 2013

First Submitted That Met QC Criteria

February 19, 2013

First Posted (Estimate)

February 20, 2013

Study Record Updates

Last Update Posted (Estimate)

August 7, 2013

Last Update Submitted That Met QC Criteria

August 6, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • XP200 3.25 MHZ RF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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