NCT05524662

Clinical and Histological Evaluation of BTL-785F Device for Non-invasive Treatment of Face

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: BTL Industries Ltd. · Industry
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the clinical efficacy, safety and the performance of the BTL-785-7 applicator of the BTL-785F system for non-invasive treatment of facial wrinkles and overall improvement of facial appearance.

Detailed description

The changes in the skin related to the connective tissue structural proteins (i. e. elastin and collagen fibers) will be assessed histologically. The study is a prospective, single-center, two-arm, open-label study. The subjects will be enrolled and assigned into two groups; Group A (RF \& EMF) and Control group, which will not receive any treatment. At the baseline visit, health status will be assessed. Inclusion and exclusion criteria will be verified and informed consent will be signed. Punch biopsies of the facial skin (preauricular area) for the examination of changes related to skin's connective tissue, and photographs of the treated area will be taken. The treatment administration phase in the treatment group will consist of four (4) treatment visits, delivered 5-10 days apart.

Conditions

• Wrinkle

Interventions

Type	Name	Description
DEVICE	BTL-785-7	Treatment with BTL-785F device (BTL-785-7 applicator) for non-invasive facial rejuvenation.

Timeline

• Start date: 2022-06-15
• Primary completion: 2022-12-10
• Completion: 2023-03-31
• First posted: 2022-09-01
• Last updated: 2023-04-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study