Fractional Radiofrequency for Treatment of Acne Scars and Wrinkles

NCT ID: NCT05827510

Last Updated: 2024-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-30
• Study Completion Date: 2021-12-10

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.

Detailed Description

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.

At the baseline visit, health status will be assessed and, if needed, additional tests will be performed. Inclusion and exclusion criteria will be verified and informed consent will be signed. In addition photographs of the treated area will be taken.

The treatment administration phase in both study groups will consist of three (3) treatment visits, delivered 2-5 weeks apart. Subjects of both groups will receive treatment with the insulated or non-insulated microneedle tip (BTL-585-4-5 or BTL-585-4-6), depending on patients' skin sensitivity, followed by the application of superficial tip 32 (BTL-585-4-7) or 64 (BTL-585-4-8), depending on the size of the treatment site. Treatment settings will be adjusted individually according to the severity of the subjects' condition.

Conditions

Acne; Wrinkle

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Acne scars

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.

Group Type: EXPERIMENTAL

BTL-585F

Intervention Type: DEVICE

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

Facial wrinkles

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.

Group Type: EXPERIMENTAL

BTL-585F

Intervention Type: DEVICE

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

Interventions

BTL-585F

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• History of bleeding coagulopathies, use of anticoagulants
• Any active condition in the treatment area, such as sores, psoriasis, eczema, rash and rosacea
• Any surgical procedure in the treatment area within the last three months or before complete healing
• Poorly controlled endocrine disorders, such as diabetes
• History of skin disorders, keloids, very dry and fragile skin
• Excessively tanned skin from sun, tanning beds or tanning creams within the last two weeks
• Botox®/collagen/fat injections or other injected bio-material in the treated area within three months prior to the treatment
• Use of non-steroidal anti-inflammatory drugs one week before and after each treatment session
• Treating over tattoo or permanent make-up
• Treating over eyelids or the lips
• Patients with allergy to anesthetics should not be treated under anesthesia
• Prior use of dermal fillers, botulinum toxin, lasers, etc. therapies in the treated area that can influence the study results at the investigator discretion
• Unwillingness/inability to not change their usual cosmetics and especially not to use ani-aging or anti-wrinkles products in the treated area during the duration of the study including the follow-up period
• Any other disease or condition (e.g. eye disease) at the investigator discretion that may pose risk to the patient or compromise the study

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

BTL Industries Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Precision Skin Institute

Davie, Florida, United States

Yael Halaas, M.D., FACS

New York, New York, United States

Countries

United States

Other Identifiers

BTL-585F_200

Identifier Type: -

Identifier Source: org_study_id