Radio Frequency Treatment for Acne

Recruiting at 4 trial locations

Overseen By Maria Shusterman, RN

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: InMode MD Ltd.

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

Disqualifiers: Cancer, Cardiac disorders, Epilepsy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

42 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a device called the Morpheus8 Applicator to determine its safety and effectiveness in treating facial acne. The device uses radio frequency energy to target various types of acne, including blackheads, pimples, and cysts. Individuals with mild to severe acne who are in good health may qualify. Participants must avoid other acne treatments and limit sun exposure during the trial. As an unphased trial, this study provides a unique opportunity to explore a new treatment option for acne.

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 prior data suggests that the InMode RF Pro System with Morpheus8 Applicator is safe for treating facial acne vulgaris?

Research has shown that the Morpheus8 device, which uses tiny needles and radio waves, is usually well-tolerated for treating various skin issues. Studies have found that this method can effectively reduce acne with minimal recovery time. However, rare cases of serious skin damage, such as facial burns, can occur, particularly if not performed correctly. Potential participants should know that while many have experienced positive results, risks exist if an experienced professional does not perform the procedure. Ensuring a qualified provider conducts the treatment reduces these risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for acne, like topical creams and oral medications, work by reducing oil production or targeting bacteria. But the Morpheus8 applicator offers something different by using radio frequency energy to treat affected areas of the skin. This method promotes collagen production and remodeling deep within the skin layers, potentially targeting the root causes of acne more effectively. Researchers are excited about this approach because it may offer a non-invasive alternative that can improve skin texture and reduce acne scars, providing benefits that go beyond just controlling breakouts.

What evidence suggests that the Morpheus8 Applicator is effective for treating acne?

Research has shown that the Morpheus8 device, which participants in this trial will receive, may help treat facial acne. In one study, many patients experienced at least a 50% reduction in acne after 12 weeks. This device uses radio frequency (RF) technology, known for treating skin issues with minimal recovery time. RF sends energy under the skin to reduce acne and improve skin texture. Overall, early results suggest that Morpheus8 could be a good option for people with mild to severe acne. ^{1 2 3 4 6}

Who Is on the Research Team?

Anna M Chapas, MD

Principal Investigator

Jole L Cohen, MD

Principal Investigator

Unafilliated

Are You a Good Fit for This Trial?

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.

I have or had cancer or a condition that could turn into cancer in the area being treated.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Morpheus8 Applicator

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.

How Is the Trial Designed?

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

Morpheus8 Applicator is already approved in United States, European Union for the following indications:

Approved in United States as InMode RF Pro System with Morpheus8 Applicator for:

• Electrocoagulation and hemostasis in dermatological procedures
• Treatment of mild, moderate, and severe facial acne vulgaris

Approved in European Union as InMode RF Pro System with Morpheus8 Applicator for:

• Electrocoagulation and hemostasis in dermatological procedures

Who Is Running the Clinical Trial?

InMode MD Ltd.

Lead Sponsor

Trials

26

Recruited

1,500+

Published Research Related to This Trial

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]

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 radiofrequency (RF) microneedling is a minimally invasive procedure that effectively treats various dermatologic conditions, including skin laxity, acne, and scarring.

This technique, specifically using the Morpheus8 device, offers significant benefits with reduced downtime compared to more invasive treatments, making it an appealing option for patients seeking skin improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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) microneedling, particularly with the Morpheus8 device, is a safe and effective treatment for various skin conditions across all skin types.

Morpheus8 stands out among similar devices due to its unique technological advancements, making it a preferred choice for practitioners seeking minimally invasive skin rejuvenation options.

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05830968

Safety and Efficacy of Radio Frequency for the Treatment ... 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 ...

2. withpower.com withpower.com/trial/phase-acne-vulgaris-4-2023-cf06e

Radio Frequency Treatment for Acne Trial Overview The trial tests the safety and effectiveness of a Radio Frequency device called Morpheus8 for treating different levels of facial acne vulgaris.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35916259/

Dermatologic facial applications of Morpheus8 fractional ... Fractional radiofrequency (RF) microneedling offers an effective method for addressing a variety of dermatologic conditions with reduced downtime.

4. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/49/NCT03769649/Prot_SAP_000.pdf

Clinical Evaluation of Safety and Efficacy of The CelluTite ... This prospective study is intended to evaluate the safety and efficacy of a new CelluTite RFAL handpiece combined with Morpheus8 handpiece for the treatment of ...

5. inmodemd.com inmodemd.com/wp-content/uploads/2023/01/PeerRev_JOCD_M8Cellulite_NURWAC.pdf

A clinical study to evaluate the safety and efficacy ... Hence, our objective was to evaluate the safety and efficacy of the Morpheus8 Body 40- pin tip at a depth of up to 6 mm for treat- ment of the thighs to improve ...

6. accessdata.fda.gov accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=20202341&pc=PBX

MAUDE Adverse Event Report: INMODE LTD. MORPHEUS8 (b)(6) was the provider that done this procedure and literally melted my face causing severe facial damage especially to my right eye, she used the needle depth ...