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Radiofrequency Treatment for Inflammatory Acne

This study is testing a device called the InMode RF Pro System with the Morpheus8 face tip applicator to see how safe and effective it is for treating mild to severe inflammatory acne (acne vulgaris). You might be able to join if you are 16 years or older, in good general health, and have mild, moderate, or severe acne with 10-100 inflammatory lesions. The main goal is to see what percentage of participants show improvement in their acne after 3 months. The current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 42 participants. It is a prospective, multicenter clinical study.
What's involved
Eligible participants will receive two treatments with the Morpheus8 device. You will also have two follow-up visits, one month and three months after your second treatment. The total study duration is expected to be about 6 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 3 months after the second treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05830968

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

UNKNOWN
NAAges 16+InterventionalTreatment
InMode MD Ltd.
~42 participants
Updated 2024-05-29 on ClinicalTrials.gov
What's tested:Morpheus8 Applicator Radiofrequency device

At a glance

Recruiting sites
2 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percent of responder
Measured over Month 3

Conditions

Inflammatory Acne Vulgaris

Explore related trials

Acne

Where it's being run

4 sites across 4 states
Arizona1
Colorado1
New York1
Texas1

Study leadership

  • Anna M Chapas, MD · PRINCIPAL_INVESTIGATOR
  • Jole L Cohen, MD · PRINCIPAL_INVESTIGATOR · Unafilliated

Who to contact

Meital Matalon, MS
[email protected]
9492588870 · ext. 324
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Percent of responderMonth 3

    Percent of responders, where responders are defined as subjects with at least a 50% reduction in number of inflammatory acne lesions from baseline to 12 weeks after the last treatment, as assessed by 3 independent reviewers using clinical photographs. Success Criteria: Success will be achieved if at least 50% of enrolled subjects are responders.