NCT03548025

Safety and Efficacy of the BTL-FR2000 Device for the Treatment of Facial Wrinkles

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: BTL Industries Ltd. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Accepted

Summary

The study will evaluate safety and effectivity of the BTL-FR2000 device for the treatment of facial wrinkles.

Detailed description

Subjects will be photographed at the baseline visit. After the treatment phase, subjects will be invited for two follow-up visits - 3 and 6 months after the last therapy. They will be again photographed. Three blinded evaluators will be scoring the full face photos according to the Fitzpatrick Wrinkle Severity Scale. The improvement of the scores will be evaluated. Every subject will serve as its own control. In addition, the occurence of an AE during the whole study, as well as the therapy discomfort during the treatment phase, will be followed.

Conditions

• Wrinkle

Interventions

Type	Name	Description
DEVICE	BTL-703 (Treatment group)	Treatment with BTL-FR2000 Device

Timeline

• Start date: 2018-03-01
• Primary completion: 2019-01-01
• Completion: 2019-03-01
• First posted: 2018-06-06
• Last updated: 2018-06-08

Locations

1 site across 1 country: Bulgaria