Fractional Radiofrequency for Treatment of Acne Scars and Wrinkles

NCT05827510 | Completed FDA Device

• 1 other identifier: BTL-585F_200
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (2)

• Change in wrinkle severity

  Evaluation of wrinkle severity based on photographs before and after the study procedure.

  5 months

• Change in acne scars

  Evaluation of improvement in acne scars based on photographs before and after the study procedure.

  5 months

Secondary Outcomes (1)

• Incidence of Treatment-Related Adverse Events [Safety and Tolerability]

  5 months

Study Arms (2)

Acne scars

EXPERIMENTAL

All subjects will be treated with the BTL-585F system. Parameters' settings should be individually evaluated by the operator based on the treatment area and on the patient's medical and wound healing history. Parameters can be modified during subsequent visits, as per the practitioner's discretion.

Device: BTL-585F

Facial wrinkles

EXPERIMENTAL

All subjects will be treated with the BTL-585F system. Parameters' settings should be individually evaluated by the operator based on the treatment area and on the patient's medical and wound healing history. Parameters can be modified during subsequent visits, as per the practitioner's discretion.

Device: BTL-585F

Interventions

BTL-585F DEVICE

BTL-585F device with BTL-585-4 applicator

Acne scars; Facial wrinkles

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male or female subjects over 21 years of age seeking treatment and reduction of facial wrinkles or acne scars
• Subjects should be able to understand the investigative nature of the treatment, the possible benefits and side effects, and must sign the Informed Consent Form
• Presence of clearly visible wrinkles or acne scars in the treated area when the face is relaxed as deemed appropriate by the Investigator
• Subjects willing and able to abstain from partaking in any facial treatments other than the study procedure during study participation
• Willingness to comply with study instructions, to return to the clinic for the required visits, and to have photographs of their face taken

You may not qualify if:

• Bacterial or viral infection, acute inflammations
• Impaired immune system
• Isotretinoin in the past 12 months
• Skin related autoimmune diseases
• Radiation therapy and/or chemotherapy
• Poor healing and unhealed wounds in the treatment area
• Metal implants
• Permanent implant in the treated area
• Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body
• Facial dermabrasion, facial resurfacing, or deep chemical peeling in the treatment area within 6 months prior to the treatment
• Current or history of skin cancer, or current condition of any other type of cancer, or pre-malignant moles
• History of any type of cancer
• Active collagen diseases
• Cardiovascular diseases (such as vascular diseases, peripheral arterial disease, thrombophlebitis and thrombosis)
• Pregnancy/nursing or IVF procedure

Sponsors & Collaborators

• BTL Industries Ltd.: lead

Study Sites (2)

Precision Skin Institute

Davie, Florida, 33328, United States

Location

Yael Halaas, M.D., FACS

New York, New York, 10022, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 12, 2023
• First Posted: April 25, 2023
• Study Start: November 30, 2020
• Primary Completion: September 1, 2021
• Study Completion: December 10, 2021
• Last Updated: February 2, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)