Safety and Efficacy of Radio Frequency for the Treatment of Mild to Severe Inflammatory Acne

Launched by INMODE MD LTD. · Apr 25, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at the safety and effectiveness of a treatment called the InMode RF Pro System with a special applicator for people suffering from inflammatory acne, which can range from mild to severe. The goal is to see how well this treatment works for reducing acne on the face. The trial is currently recruiting participants who are at least 16 years old and in generally good health, with specific types of acne and a certain number of inflammatory lesions (like bumps or pus-filled spots).

If you or someone you know is interested in participating, it’s important to know that participants must agree to follow the study rules, including not using other acne treatments or changing birth control methods during the trial. They should also avoid sun exposure unless using sunscreen. The trial excludes individuals with certain medical conditions or treatments, like recent use of acne medications, active skin issues, or specific health problems that could complicate participation. Overall, this study aims to provide more information on a new way to help treat acne effectively.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subject is \>16 years of age
• • General good health confirmed by medical history and examination of the treated area.
• • Subjects with mild to severe Acne Vulgaris, defined as a baseline IGA (Investigator's Global Assessment) score of 2, 3 or 4 and 10-100 inflammatory lesions (papules or pustules).
• • The patients should be willing to comply with the study procedure and schedule, including the follow up visits, and will refrain from using any other acne treatment methods during the entire study period.
• • Willing to avoid sun/UV exposure for duration of the study unless using sunscreen.
• • Willing to refrain from starting or changing hormonal contraception for duration of study.
• • Subject understands and is willing to sign the informed consent to participate in the study. Parental (or other) guardians must provide consent for minors under the age of 18.
• • Exclusion Criteria:- Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body.
• • Patients who are under pharmacological anti-acne therapy (isotretinoin or antibiotics) for the last 6 months.
• • Use of botulinum toxin within prior 1 month.
• • Permanent implant in the treated area such as metal plates and screws, silicone implants or an injected chemical substance
• • Current or history of cancer, or premalignant condition in the treatment area.
• • Severe concurrent conditions, such as cardiac disorders, epilepsy, uncontrolled hypertension, and liver or kidney diseases.
• • Subject who are pregnant or nursing.
• • Started or changed hormonal contraceptive within prior month of study.
• • Subject is unwilling or unlikely to refrain from high UV exposure to face.
• • Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications.
• • Patients with history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treatment area
• • Poorly controlled endocrine disorders, such as diabetes or thyroid dysfunction.
• • Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash.
• • History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin.
• • History of bleeding coagulopathies or use of anticoagulants in the last 10 days.
• • Any surgery in treated area within 3 months prior to treatment.
• • Subject received other treatments such as light, CO2 laser or RF in the treatment area within 6 months of study start date.
• • Simultaneous participation in another investigator drug or device study or completion of the follow-up phase for the primary endpoint of any previous study less than 30 days prior to the first evaluation in this study.
• • Subject that has any condition that, at the investigator's discretion, renders the subject unsuitable for participation in this clinical research study.