NCT01795417

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2012

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 20, 2013

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

August 7, 2013

Status Verified

August 1, 2013

Enrollment Period

4 months

First QC Date

February 18, 2013

Last Update Submit

August 6, 2013

Conditions

Periorbital Wrinkles

Keywords

wrinklesrhytidsperiorbital

Outcome Measures

Primary Outcomes (1)

  • 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

    3 months

Study Arms (1)

XP200 device RF treatments

EXPERIMENTAL

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 XP200Device: XP200 RF device

Interventions

RF XP200DEVICE

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

XP200 device RF treatments
XP200 RF deviceDEVICE

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

XP200 device RF treatments

Eligibility Criteria

Age35 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years old
  • periorbital wrinkles

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Georgi Petkov

    BTL Industries Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2013

First Posted

February 20, 2013

Study Start

August 1, 2012

Primary Completion

December 1, 2012

Study Completion

March 1, 2013

Last Updated

August 7, 2013

Record last verified: 2013-08