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Radiofrequency Device

Radio Frequency Treatment for Acne

N/A
Recruiting
Led By Anna M Chapas, MD
Research Sponsored by InMode MD Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
Subject is >16 years of age
Must not have
Patients with history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treatment area
Current or history of cancer, or premalignant condition in the treatment area
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 3
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a device to safely and effectively treat acne on the face, from mild to severe.

Who is the study for?
This trial is for individuals over 16 with mild to severe facial acne who are in good health and willing to avoid sun exposure or use sunscreen. They must not be using other acne treatments, changing hormonal contraception, or have had certain procedures like RF treatment in the past 6 months. Those with metal implants, skin cancer history, active infections like herpes in the area, immune disorders, or on anticoagulants can't participate.
What is being tested?
The trial tests the safety and effectiveness of a Radio Frequency device called Morpheus8 for treating different levels of facial acne vulgaris. Participants will undergo this non-invasive treatment and follow up visits to assess changes in their acne condition without using any other acne therapies during the study.
What are the potential side effects?
While not explicitly listed here, potential side effects may include temporary redness, swelling at the treatment site, discomfort during application, rare risk of burns from heat generated by radiofrequency energy and possible aggravation of existing skin conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have mild to severe acne with 10-100 inflamed spots.
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I am older than 16 years.
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I agree not to start or change my birth control during the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had conditions like cold sores in the area to be treated.
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I have or had cancer or a condition that could turn into cancer in the area being treated.
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I have no active skin conditions like sores or eczema in the treatment area.
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I do not have severe heart, epilepsy, high blood pressure, or liver/kidney diseases.
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My diabetes or thyroid condition is not well-managed.
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I am not willing or able to avoid high UV exposure to my face.
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I have a permanent implant like metal plates or silicone in the treated area.
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I haven't taken acne medication like isotretinoin or antibiotics in the last 6 months.
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I haven't had treatments like light therapy or lasers in the area of interest for 6 months.
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My immune system is weak due to a condition like AIDS or medication.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 3
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 3 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percent of responder
Secondary study objectives
Absolute change in non-inflammatory acne lesions
Absolute change in number of inflammatory acne lesions
Percent change in non-inflammatory acne lesions
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Device treatmentExperimental Treatment1 Intervention
Treatment area will include affected areas over the entire face (presence of comedones, pustules, papules, nodules and cysts

Find a Location

Who is running the clinical trial?

InMode MD Ltd.Lead Sponsor
24 Previous Clinical Trials
1,348 Total Patients Enrolled
Anna M Chapas, MDPrincipal Investigator
Jole L Cohen, MDPrincipal InvestigatorUnafilliated

Media Library

Morpheus8 Applicator (Radiofrequency Device) Clinical Trial Eligibility Overview. Trial Name: NCT05830968 — N/A
Acne Research Study Groups: Device treatment
Acne Clinical Trial 2023: Morpheus8 Applicator Highlights & Side Effects. Trial Name: NCT05830968 — N/A
Morpheus8 Applicator (Radiofrequency Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05830968 — N/A
~9 spots leftby May 2025
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