Radio Frequency Treatment for Acne

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen by Jole L Cohen, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: InMode MD Ltd.

Must not be taking: Isotretinoin, Antibiotics, Anticoagulants, others

Disqualifiers: Cancer, Cardiac disorders, Epilepsy, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

The aim of this trial is to evaluate the safety and efficacy of the InMode RF Pro System with the Morpheus8 face tip (24 pins) applicator for the treatment of mild, moderate and severe, facial acne vulgaris

Will I have to stop taking my current medications?

The trial requires that you refrain from using any other acne treatment methods during the study. If you have been on anti-acne medications like isotretinoin or antibiotics in the last 6 months, you may not be eligible to participate.

What data supports the effectiveness of the treatment Morpheus8 Applicator, InMode RF Pro System with Morpheus8 Applicator, Morpheus8 Face Tip, Morpheus8 Body Applicator for acne?

Research shows that radiofrequency microneedling, like the Morpheus8, is effective for treating various skin conditions, including acne and acne scars, with minimal downtime. Studies have demonstrated its safety and effectiveness in improving moderate to severe acne lesions and scars. ^{1 2 3 4 5}

How is the Morpheus8 treatment for acne different from other treatments?

The Morpheus8 treatment for acne is unique because it uses fractional radiofrequency microneedling, which combines tiny needles and radiofrequency energy to target deeper layers of the skin. This approach is minimally invasive, offers reduced recovery time compared to more invasive procedures, and is effective for a variety of skin types and conditions, including acne and scarring. ^{1 2 4 5 6}

Research Team

Anna M Chapas, MD

Principal Investigator

Jole L Cohen, MD

Principal Investigator

Unafilliated

Eligibility Criteria

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.

Inclusion Criteria

I have mild to severe acne with 10-100 inflamed spots.

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

I agree to follow the study's schedule and not use other acne treatments.

Exclusion 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.

Subject that has any condition that, at the investigator's discretion, renders the subject unsuitable for participation in this clinical research study

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive treatment with the InMode RF Pro System with the Morpheus8 applicator for facial acne vulgaris

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Treatment Details

Interventions

• Morpheus8 Applicator (Radiofrequency Device)

Trial Overview 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.

Participant Groups

Group I: Device treatment Experimental Treatment 1 Intervention

Treatment area will include affected areas over the entire face (presence of comedones, pustules, papules, nodules and cysts

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Clinical Center for Cosmetic Laser Treatment Dallas, TX

UT Southwestern Medical Center Dallas, TX

AboutSkin Research, LLC Greenwood Village, CO

Avant Dermatology Aesthetics Oro Valley, AZ

More Trial Locations

Who Is Running the Clinical Trial?

InMode MD Ltd.

Lead Sponsor

Trials

26

Patients Recruited

1,500+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dermatologic facial applications of Morpheus8 fractional radiofrequency microneedling. Hendricks, AJ., Farhang, SZ.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Radiofrequency Microneedling in the Facial Plastic Surgeon's Practice: A Review. Magro, I., Kochhar, A., Arnaoutakis, D., et al.[2022]

In a study of 18 patients with moderate to severe acne vulgaris, treatment with a fractionated microneedle radiofrequency device resulted in significant clinical improvement, with 10 patients showing at least grade 3 improvement in their acne lesions after two treatment sessions.

The treatment was found to be safe, as no patients experienced worsening of their inflammatory acne lesions, indicating that fractionated microneedle RF is a promising option for managing acne without exacerbating the condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of fractionated microneedle radiofrequency for the treatment of inflammatory acne vulgaris in 18 Korean patients. Lee, SJ., Goo, JW., Shin, J., et al.[2019]

Radiofrequency (RF) therapy is a versatile tool in aesthetic dermatology, utilizing different systems (monopolar, bipolar, multipolar) and delivery methods (like fractional needling and non-contact devices) to effectively remodel skin and adipose tissue.

The article highlights the importance of understanding tissue characteristics and technical parameters that influence RF therapy outcomes, emphasizing safety and reduced patient downtime as key considerations for effective treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Introduction and overview of radiofrequency treatments in aesthetic dermatology. Delgado, AR., Chapas, A.[2022]

Fractional bipolar radiofrequency (RF) treatment using the eTwo™ system showed high efficacy for improving moderate to severe acne scars, with significant improvement observed after 3-5 treatments in 12 patients.

The treatment was well-tolerated, with only mild and transient side effects like erythema and scab formation, and patient satisfaction was high, with 50% reporting satisfaction and the other 50% reporting very high satisfaction with the results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical evaluation of the efficacy and safety of fractional bipolar radiofrequency for the treatment of moderate to severe acne scars. Verner, I.[2022]

The study demonstrated that a micro-insulated needle radio frequency (RF) applicator effectively destroyed sebaceous glands in a rabbit ear acne model, which could help reduce acne symptoms.

This method not only inhibited the formation of comedones but also reduced TNF-alpha release, suggesting a mechanism that involves both gland destruction and the initiation of the wound healing process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeting of sebaceous glands to treat acne by micro-insulated needles with radio frequency in a rabbit ear model. Kwon, TR., Choi, EJ., Oh, CT., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Dermatologic facial applications of Morpheus8 fractional radiofrequency microneedling. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Transcutaneous Radiofrequency Microneedling in the Facial Plastic Surgeon's Practice: A Review. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Use of fractionated microneedle radiofrequency for the treatment of inflammatory acne vulgaris in 18 Korean patients. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Introduction and overview of radiofrequency treatments in aesthetic dermatology. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Clinical evaluation of the efficacy and safety of fractional bipolar radiofrequency for the treatment of moderate to severe acne scars. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Targeting of sebaceous glands to treat acne by micro-insulated needles with radio frequency in a rabbit ear model. [2021]