NCT05987917

Clinical and Histological Evaluation of BTL-785F Non-invasive Treatment for Facial Rejuvenation

• 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-785-2 applicator of the BTL-785F system for non-invasive treatment of facial wrinkles and correcting facial skin laxity.

Detailed description

The changes in the skin tissue related to the levels of hyaluronic acid (HA) will be assessed histologically. The study is a prospective, single-center, three-arm, open-label study. The subjects will be enrolled and assigned into two treatment groups; group A (RF \& USN) 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 follow-up visits. Additionally, a Control will be included to verify the treatment outcomes. 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 for the examination of changes related to HA levels and photographs of the treated area will be taken. The treatment administration phase in both treatment groups will consist of four (4) treatment visits, delivered 7 - 14 days apart.

Conditions

• Wrinkle

Interventions

Type	Name	Description
DEVICE	BTL-785-2	Treatment with BTL-785 device (BTL-785-2 applicator) for non-invasive facial rejuvenation
OTHER	No Treatment	The subject who will serve as control will not be treated with the study device.

Timeline

• Start date: 2021-01-25
• Primary completion: 2022-01-03
• Completion: 2022-01-03
• First posted: 2023-08-14
• Last updated: 2024-02-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study