NCT05827510

Fractional Radiofrequency for Treatment of Acne Scars and Wrinkles

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: BTL Industries Ltd. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the clinical efficacy, safety and the performance of the fractional radiofrequency delivered by the BTL-585-4 applicator of the BTL-585F system for non-invasive treatment of acne scars and facial wrinkles. The study is a prospective multicenter open label two-arm study. The subjects will be enrolled and assigned into two study groups, according to their indication; group A (acne scars) and B (facial wrinkles), each study group will receive treatment of different conditions. Subjects of both groups will be required to complete three (3) treatment visits and two to three follow-up visits.

Detailed description

This study will evaluate the clinical efficacy, safety and the performance of the fractional radiofrequency delivered by the BTL-585-4 applicator of the BTL-585F system for non-invasive treatment of acne scars and facial wrinkles. The study is a prospective multicenter open label two-arm study. The subjects will be enrolled and assigned into two study groups, according to their indication; group A (acne scars) and B (facial wrinkles), each study group will receive treatment of different conditions. Subjects of both groups will be required to complete three (3) treatment visits and two to three follow-up visits. At the baseline visit, health status will be assessed and, if needed, additional tests will be performed. Inclusion and exclusion criteria will be verified and informed consent will be signed. In addition photographs of the treated area will be taken. The treatment administration phase in both study groups will consist of three (3) treatment visits, delivered 2-5 weeks apart. Subjects of both groups will receive treatment with the insulated or non-insulated microneedle tip (BTL-585-4-5 or BTL-585-4-6), depending on patients' skin sensitivity, followed by the application of superficial tip 32 (BTL-585-4-7) or 64 (BTL-585-4-8), depending on the size of the treatment site. Treatment settings will be adjusted individually according to the severity of the subjects' condition.

Conditions

• Acne
• Wrinkle

Interventions

Type	Name	Description
DEVICE	BTL-585F	BTL-585F device with BTL-585-4 applicator

Timeline

• Start date: 2020-11-30
• Primary completion: 2021-09-01
• Completion: 2021-12-10
• First posted: 2023-04-25
• Last updated: 2024-02-02

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study