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Radiofrequency Device
Radio Frequency Treatment for Acne
N/A
Waitlist Available
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 3
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I have mild to severe acne with 10-100 inflamed spots.
Select...
I am older than 16 years.
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I agree not to start or change my birth control during the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 3
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 3
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percent of responder
Secondary outcome measures
Absolute change in non-inflammatory acne lesions
Absolute change in number of inflammatory acne lesions
Percent change in non-inflammatory acne lesions
+3 moreTrial 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
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Who is running the clinical trial?
InMode MD Ltd.Lead Sponsor
23 Previous Clinical Trials
1,323 Total Patients Enrolled
Anna M Chapas, MDPrincipal Investigator
Jole L Cohen, MDPrincipal InvestigatorUnafilliated
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had conditions like cold sores in the area to be treated.I haven't used blood thinners or had bleeding disorders in the last 10 days.I have or had cancer or a condition that could turn into cancer in the area being treated.I have mild to severe acne with 10-100 inflamed spots.I have no active skin conditions like sores or eczema in the treatment area.I do not have severe heart, epilepsy, high blood pressure, or liver/kidney diseases.My diabetes or thyroid condition is not well-managed.I am not willing or able to avoid high UV exposure to my face.I have a permanent implant like metal plates or silicone in the treated area.I agree to follow the study's schedule and not use other acne treatments.I haven't taken acne medication like isotretinoin or antibiotics in the last 6 months.I am older than 16 years.I am willing to avoid sun exposure or use sunscreen during the study.I agree not to start or change my birth control during the study.I haven't had treatments like light therapy or lasers in the area of interest for 6 months.I have not used botulinum toxin in the last month.You have a history of skin problems, like keloids or slow healing wounds, and very dry or fragile skin.I haven't had surgery in the area to be treated in the last 3 months.My immune system is weak due to a condition like AIDS or medication.
Research Study Groups:
This trial has the following groups:- Group 1: Device treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are any volunteers being accepted for this experiment currently?
"According to the clinicaltrials.gov website, this particular medical trial is no longer recruiting patients. Initially published on May 1st 2023 and last updated April 25th of the same year, it has been superseded by 36 other active studies currently seeking participants."
Answered by AI
Who else is applying?
What site did they apply to?
UT Southwestern Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
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