NCT03831477

Clinical Evaluation of Fractional Radiofrequency for the Treatment and Reduction of Facial Wrinkles

Clinical Evaluation of the Safety and Performance of Fractional Radiofrequency for the Treatment and Reduction of Facial Wrinkles

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Venus Concept · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Accepted

Summary

Prospective, single centre, evaluator-blind study of the safety and performance of fractional radiofrequency (RF) for the treatment and reduction of facial wrinkles.

Detailed description

The study will evaluate 15 subjects requesting treatment of their facial wrinkles. The study will involve three treatments on both sides of the face with 3-5 week intervals between each treatment. Subjects will be followed at 6 and 12 weeks after their last treatment. Analysis will be performed on all subjects who receive at least one treatment. An additional histological analysis will be conducted including up to 12 of the participating subjects.

Conditions

• Rhytides
• Wrinkle

Interventions

Type	Name	Description
DEVICE	Venus Viva	The Venus Viva™ is a non-invasive medical aesthetic device, intended for use in dermatologic and general surgical procedures, requiring ablation and resurfacing of the skin, using the Viva applicator.

Timeline

• Start date: 2018-12-12
• Primary completion: 2019-08-09
• Completion: 2019-08-09
• First posted: 2019-02-05
• Last updated: 2023-09-06
• Results posted: 2023-09-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study