NCT05929625

Radiofrequency and Ultrasound for Improvement of Skin Laxity and Wrinkles: Efficacy and Safety Evaluation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (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 radiofrequency heating and ultrasound delivered by the BTL-585-2 applicator of the BTL-585F system for non-invasive treatment of facial wrinkles and correcting facial skin laxity. The study is a prospective multicenter single-blinded two-arm study. The subjects will be enrolled and assigned into two study groups; group A (RF \& US) and B (only RF) which will receive a treatment with different settings. Subjects of both groups will be required to complete four (4) treatment visits and two to three follow-up visits.

Detailed description

This study will evaluate the clinical efficacy, safety and the performance of radiofrequency heating and ultrasound delivered by the BTL-585-2 applicator of the BTL-585F system for non-invasive treatment of facial wrinkles and correcting facial skin laxity. The study is a prospective multicenter single-blinded two-arm study. The subjects will be enrolled and assigned into two study groups; group A (RF \& US) and B (only RF) which will receive a treatment with different settings. Subjects of both groups will be required to complete four (4) 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. Skin hydration and elasticity in the treatment area will be measured. In addition photographs of the treated area will be taken. The treatment administration phase in both study groups will consist of four (4) treatment visits, delivered 7 - 14 days apart. Group A will receive treatment with active ultrasound (ON) and the intensity of radiofrequency will be set to a maximum tolerable level. The group B will receive treatment with the intensity of radiofrequency set to a maximum tolerable level, but without active ultrasound (OFF). At every treatment visit after the first, prior to the procedure, the participants will be assessed for adverse effects resulting from the previous treatment(s) with the BTL-585F device. At the last therapy visit, photographs of the treated area will be taken. In addition, subjects will receive Subject Satisfaction Questionnaire and Therapy Comfort Questionnaire to fill in. Skin hydration and elasticity in the treatment area will be measured.

Conditions

• Skin Laxity

Interventions

Type	Name	Description
DEVICE	BTL-585-2 RF+US	The subjects of RF+US group will receive four simultaneous RF+US treatments of the entire face area including forehead, upper and lower cheeks and area around eyes.
DEVICE	BTL-585-2 RF	The subjects of RF only study group will receive four RF treatments of the entire face area including forehead, upper and lower cheeks and area around eyes.

Timeline

• Start date: 2020-10-28
• Primary completion: 2022-02-23
• Completion: 2022-05-31
• First posted: 2023-07-03
• Last updated: 2023-07-03

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study