Radiofrequency for Acne

Overseen By Lori Marzilli-Kahler

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Pollogen

Must be taking: Tetracycline antibiotics

Must not be taking: Anticoagulants, Immunosuppressives, Retinoids

Disqualifiers: Pregnancy, Cancer, Cardiac disorders, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 6-8 weeks

30 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

You can continue taking tetracycline antibiotics for your acne, but you need to stop using other oral anti-acne medications for 6 months and topical anti-acne medications for 1 month before starting the trial.

Is fractional radiofrequency treatment safe for humans?

Research shows that fractional radiofrequency treatments, including those using systems like TriFractional and Legend Pro+, are generally safe for humans. Studies report mild and temporary side effects like redness and minimal scabbing, with no significant or unexpected adverse events. ^{1 2 3 4 5}

How is the triLift/Legend Pro+ Fractional RF System treatment different from other acne treatments?

The triLift/Legend Pro+ Fractional RF System uses radiofrequency energy to target deeper skin layers, promoting collagen production and skin remodeling without damaging the surface, which is different from traditional topical or oral acne treatments that may have side effects. This approach can improve both active acne and acne scars with minimal downtime and discomfort. ^{1 3 6 7 8}

What is the purpose of this trial?

Evaluation of the safety and efficacy of fractional radiofrequency for the treatment of moderate to severe acne vulgaris.

Research Team

Yuri Vinshtok

Principal Investigator

Pollogen Ltd.

Eligibility Criteria

This trial is for 18-25 year-olds with moderate to severe facial acne, defined by specific criteria. Participants must be on tetracycline antibiotics and off other acne treatments for set periods before the study. They should have a balanced acne condition on both sides of their face and agree to birth control if applicable.

Inclusion Criteria

I have read and signed the consent form.

I have similar acne severity on both sides of my face with at least 15 inflamed spots.

I am willing and able to follow the study's treatment and follow-up plan.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive three treatments of fractional radiofrequency, randomized with combination antibiotic/fractional radiofrequency therapy

6-8 weeks

3 treatment visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

9 months

3 visits (3, 6, and optional 9 months post-treatment)

Treatment Details

Interventions

• triLift/Legend Pro+ Fractional RF System

Trial Overview The trial tests the safety and effectiveness of fractional radiofrequency (RF) using triLift/Legend Pro+ system in treating moderate to severe acne vulgaris compared to standard treatments.

Participant Groups

Group I: Single Arm Experimental Treatment 1 Intervention

Open(self-controlled) split-face design study. Thirty participants will undergo the treatments on one side of the face (buccal area). Treatments will be randomized with combination antibiotic/ FRF therapy.

triLift/Legend Pro+ Fractional RF System is already approved in United States, European Union for the following indications:

Approved in United States as Legend Pro+ for:

• Skin resurfacing
• Treatment of mild to moderate wrinkles and rhytids
• Acne scars
• Stretch marks

Approved in European Union as Legend Pro+ for:

• Skin resurfacing
• Treatment of mild to moderate wrinkles and rhytids
• Acne scars
• Stretch marks
• Body contouring
• Cellulite reduction

Who Is Running the Clinical Trial?

Pollogen

Lead Sponsor

Trials

4

Recruited

140+

Lumenis Be Ltd.

Industry Sponsor

Trials

39

Recruited

1,500+

Findings from Research

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 fractional radio frequency (RF) treatments using coated pin tips are safe and effective for skin rejuvenation in patients with Fitzpatrick skin type VI, with no significant unexpected adverse events reported.

After three treatment sessions, participants showed improvements in skin characteristics such as wrinkles, acne scars, and overall facial appearance, evaluated at follow-up visits six and twelve weeks post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Evaluation of Safety and Efficacy of Fractional Radiofrequency Facial Treatment of Skin Type VI Patients Battle, F., Battle, S.[2019]

In a study involving 15 subjects with acne, three sessions of fractional radiofrequency (RF) treatment led to significant improvements in active acne and acne scars, with evaluations conducted up to 6 months post-treatment.

The treatment was found to be safe, with no significant or unexpected adverse events reported, supporting its use as an effective option for managing acne and its associated scars.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Fate of Active Acne and Acne Scars Following Treatment With Fractional Radiofrequency Katz, BE.[2020]

Bipolar fractional radiofrequency (FRF) therapy significantly improved atrophic acne scars and reduced acne lesions in 23 Japanese patients over five treatment sessions, with marked improvements in scar volume and a significant decrease in acne lesions compared to baseline.

The treatment was well-tolerated with minimal side effects, and patients reported significant improvements in their quality of life, along with reductions in sebum levels, skin roughness, and scar depth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical studies of the treatment of facial atrophic acne scars and acne with a bipolar fractional radiofrequency system. Kaminaka, C., Uede, M., Matsunaka, H., et al.[2019]

The TriFractional technology using the 3F Applicator is a safe and effective treatment for facial wrinkles, with no significant adverse side effects reported in a study of 32 subjects followed for 3 months.

80% of subjects showed improvement in wrinkle appearance, and 83.3% felt the results met their expectations, indicating high satisfaction with the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of safety and efficacy of the TriFractional RF technology for treatment of facial wrinkles. Gold, MH., Adelglass, J.[2019]

The combination of radiofrequency (RF) energy and 410-nm blue light has shown excellent efficacy in treating grade 4 cystic acne and acne scars, with significant improvement noted by both the patient and investigators.

This treatment approach offers a safe alternative to traditional acne therapies, as it minimizes downtime and reduces the risk of negative side effects associated with conventional topical and oral treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combination of a new radiofrequency device and blue light for the treatment of acne vulgaris. Braun, M.[2007]

The latest generation of radiofrequency (RF) technology, known as 3DEEP, allows for deeper penetration into the skin while minimizing damage to the epidermis, making it safer and more effective than earlier RF devices.

Clinical studies demonstrated that after 6 sessions of multisource RF treatment, patients experienced significant improvements in skin structure, including reduced wrinkles and a long-term reduction in subcutaneous fat thickness, indicating effective collagen remodeling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel multi-source phase-controlled radiofrequency technology for non-ablative and micro-ablative treatment of wrinkles, lax skin and acne scars. Elman, M., Harth, Y.[2021]

Both fractional bipolar radiofrequency (RF) and fractional erbium-doped glass treatments significantly improved atrophic acne scars in a study of 20 Thai subjects, with no statistically significant difference in effectiveness between the two methods.

While both treatments had side effects like pain and scab formation, the fractional erbium-doped glass caused more pain and had a longer scab shedding duration, with one case of postinflammatory hyperpigmentation noted only in that group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of a fractional bipolar radiofrequency device and a fractional erbium-doped glass 1,550-nm device for the treatment of atrophic acne scars: a randomized split-face clinical study. Rongsaard, N., Rummaneethorn, P.[2022]

References

1. 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]

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

Clinical Evaluation of Safety and Efficacy of Fractional Radiofrequency Facial Treatment of Skin Type VI Patients [2019]

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

The Fate of Active Acne and Acne Scars Following Treatment With Fractional Radiofrequency [2020]

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

Clinical studies of the treatment of facial atrophic acne scars and acne with a bipolar fractional radiofrequency system. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Evaluation of safety and efficacy of the TriFractional RF technology for treatment of facial wrinkles. [2019]

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

Combination of a new radiofrequency device and blue light for the treatment of acne vulgaris. [2007]

7. Japan pubmed.ncbi.nlm.nih.gov

Novel multi-source phase-controlled radiofrequency technology for non-ablative and micro-ablative treatment of wrinkles, lax skin and acne scars. [2021]

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

Comparison of a fractional bipolar radiofrequency device and a fractional erbium-doped glass 1,550-nm device for the treatment of atrophic acne scars: a randomized split-face clinical study. [2022]