Safety and Efficacy of XP200 Radiofrequency Treatment of Wrinkles

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.

Completed

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Key information

Conditions

Periorbital Wrinkles

Age range

35 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

35-60 years old
periorbital wrinkles

Exclusion criteria

Treatment and study plan

RF XP200

Device

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

XP200 RF device

Device

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

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

BTL Industries Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2012
Study completion: 2013
First posted: Feb 20, 2013
Registry last updated: Aug 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed