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CompletedNCT01795417Updated Aug 7, 2013

Safety and Efficacy of XP200 Radiofrequency Treatment of Wrinkles

An interventional study of RF XP200 and XP200 RF device in Periorbital Wrinkles, sponsored by BTL Industries Ltd.. Completed. Open to participants aged 35 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-08-07.

Sponsored by BTL Industries Ltd. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
35 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Periorbital Wrinkles

Keywords

  • wrinkles
  • rhytids
  • periorbital
03

In context

Lead sponsor

BTL Industries Ltd. is the lead sponsor of 71 studies on the registry; 4 are open to participants now.

Of its 34 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 35-60 years old
  • periorbital wrinkles

Exclusion criteria

Exclusion Criteria:

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • 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 · Device: XP200 RF device

Interventions

  • DeviceRF XP200

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

  • DeviceXP200 RF device

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

06

What researchers measure

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

    Time frame: 3 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01795417
Lead sponsor
BTL Industries Ltd.
Responsible party
Sponsor
First posted
Feb 20, 2013
Start date
Aug 2012
Primary completion
Dec 2012
Completion
Mar 2013
Last update
Aug 7, 2013

Study contacts

Georgi Petkov
study director · BTL Industries Ltd.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.

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