42 Participants Needed

Radio Frequency Treatment for Acne

Recruiting at 4 trial locations
MM
MS
Overseen ByMaria Shusterman, RN
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

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.12345

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.12456

Research Team

AM

Anna M Chapas, MD

Principal Investigator

JL

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.
See 4 more

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
See 16 more

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
Trial OverviewThe 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
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

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

๐Ÿ‡บ๐Ÿ‡ธ
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
๐Ÿ‡ช๐Ÿ‡บ
Approved in European Union as InMode RF Pro System with Morpheus8 Applicator for:
  • Electrocoagulation and hemostasis in dermatological procedures

Find a Clinic Near You

Who Is Running the Clinical Trial?

InMode MD Ltd.

Lead Sponsor

Trials
26
Recruited
1,500+

Findings from Research

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

References

Dermatologic facial applications of Morpheus8 fractional radiofrequency microneedling. [2022]
Transcutaneous Radiofrequency Microneedling in the Facial Plastic Surgeon's Practice: A Review. [2022]
Use of fractionated microneedle radiofrequency for the treatment of inflammatory acne vulgaris in 18 Korean patients. [2019]
Introduction and overview of radiofrequency treatments in aesthetic dermatology. [2022]
Clinical evaluation of the efficacy and safety of fractional bipolar radiofrequency for the treatment of moderate to severe acne scars. [2022]
Targeting of sebaceous glands to treat acne by micro-insulated needles with radio frequency in a rabbit ear model. [2021]