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Safety and Efficacy of XP200 Radiofrequency Treatment of Wrinkles

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01795417
Enrollment
50
Registered
2013-02-20
Start date
2012-08-31
Completion date
2013-03-31
Last updated
2013-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periorbital Wrinkles

Keywords

wrinkles, rhytids, periorbital

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.

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

Sponsors

BTL Industries Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
35 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* 35-60 years old * periorbital wrinkles

Design outcomes

Primary

MeasureTime frameDescription
Improvement in wrinkles appearance3 monthsOne 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026