Using radio frequency to treat inflammatory acne
Clinical Evaluation of Safety and Efficacy of the InMode RF Pro System With the Morpheus8 Applicator for the Treatment of Mild to Severe Inflammatory Acne Vulgaris
This study is testing whether a new radiofrequency device can help people with mild to severe inflammatory acne clear up their skin.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | InMode MD Ltd. Industry-sponsored |
| Locations | 4 sites (Oro Valley, Arizona and 3 other locations) |
| Trial ID | NCT05830968 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the safety and effectiveness of the InMode RF Pro System with the Morpheus8 face tip applicator for treating mild to severe inflammatory acne vulgaris. It is a prospective, multicenter clinical study that aims to assess how well this radiofrequency device can reduce acne lesions. Participants will undergo treatment and be monitored for their response and any side effects throughout the study period.
Who should consider this trial
Good fit: Ideal candidates are individuals over 16 years old with mild to severe inflammatory acne and a willingness to comply with study protocols.
Not a fit: Patients with active electrical implants, such as pacemakers, will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients suffering from inflammatory acne.
How similar studies have performed: While similar approaches using radiofrequency for acne treatment have been explored, this specific application with the Morpheus8 device is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Oro Valley, Arizona and 3 other locations
- Avant Dermatology Aesthetics — Oro Valley, Arizona, United States (Recruiting)
- AboutSkin Research, LLC — Greenwood Village, Colorado, United States (Active_not_recruiting)
- UnionDerm — New York, New York, United States (Active_not_recruiting)
- UT Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Anna M Chapas, MD
- Study coordinator: Meital Matalon, MS
- Email: meital.matalon@inmodemd.com
- Phone: 9492588870
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.