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

NCT05929625 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2023-07-03

No results posted yet for this study

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.

Conditions

  • Skin Laxity

Interventions

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.

Sponsors & Collaborators

  • BTL Industries Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-28
Primary Completion
2022-02-23
Completion
2022-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05929625 on ClinicalTrials.gov