Fractional Radiofrequency for Treatment of Acne Scars and Wrinkles
NCT05827510 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31
Last updated 2024-02-02
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.
Conditions
- Acne
- Wrinkle
Interventions
- DEVICE
-
BTL-585F
BTL-585F device with BTL-585-4 applicator
Sponsors & Collaborators
-
BTL Industries Ltd.
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2020-11-30
- Primary Completion
- 2021-09-01
- Completion
- 2021-12-10
- FDA Device
- Yes
Countries
- United States
Study Locations
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