Safety and Efficacy of XP200 Radiofrequency Treatment of Wrinkles

BTL

Status: Completed

Conditions: Periorbital Wrinkles

Treatments: Device: XP200 RF device; Device: RF XP200

Study type: Interventional

Funder types: Industry

Identifiers

NCT01795417

XP200 3.25 MHZ RF

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 35 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• 35-60 years old
• periorbital wrinkles

Exclusion Criteria:

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

XP200 device RF treatments

Experimental group

Description:

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.

Treatment:

Device: XP200 RF device

Device: RF XP200