Safety and Efficacy of XP200 Radiofrequency Treatment of Wrinkles

Sponsor

BTL Industries Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT01795417

Collaborator

(none)

Enrollment

Arm

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Periorbital Wrinkles	Device: RF XP200 Device: XP200 RF device	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2012

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Mar 1, 2013

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

35-60 years old
periorbital wrinkles

Exclusion Criteria:

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

BTL Industries Ltd.

Investigators

Study Director: Georgi Petkov, BTL Industries Ltd.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

BTL Industries Ltd.

ClinicalTrials.gov Identifier:

NCT01795417

Other Study ID Numbers:

XP200 3.25 MHZ RF

First Posted:

Feb 20, 2013

Last Update Posted:

Aug 7, 2013

Last Verified:

Aug 1, 2013

Keywords provided by BTL Industries Ltd.

wrinkles

rhytids

periorbital

Study Results

No Results Posted as of Aug 7, 2013