Radiofrequency Microneedling for Rosacea

Overseen By Maria Muniz Muniz

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Must not be taking: Oxymetazoline, Brimonidine

Disqualifiers: Light sensitivity, Poor wound healing, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 36 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of radiofrequency microneedling for treating rosacea, a skin condition that causes redness and bumps. Researchers aim to determine if combining this treatment with a KTP laser (a type of laser therapy) enhances its effectiveness. They are also seeking new methods to address rosacea. Individuals with rosacea who are not using certain medications and do not have light sensitivity or scarring issues may be suitable candidates for this study. As an unphased trial, this study provides a unique opportunity to explore innovative treatments for rosacea.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using oxymetazoline or brimonidine.

What prior data suggests that radiofrequency microneedling and KTP laser therapy are safe for treating rosacea?

Research has shown that radiofrequency microneedling is generally safe and effective for treating rosacea. Studies indicate that this treatment can improve rosacea symptoms without causing serious side effects. However, some risks exist. Patients might experience pain, bleeding, or swelling at the treatment site. In rare cases, more serious issues like burns or scars may occur, particularly in sensitive areas. Despite these risks, many consider the treatment safe. It is important to discuss any concerns with a healthcare provider before beginning a new treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Radiofrequency Microneedling is unique because it combines the benefits of microneedling with the added power of radiofrequency energy to target rosacea. Unlike traditional treatments like topical antibiotics or laser therapies that mainly focus on reducing inflammation and redness, this method works by stimulating collagen production deep in the skin. Researchers are excited about this treatment because it offers the potential for more effective and long-lasting results, addressing the underlying skin structure issues that contribute to rosacea rather than just its symptoms. Additionally, the dual approach can provide a comprehensive solution to improve skin texture and reduce flare-ups.

What evidence suggests that this trial's treatments could be effective for rosacea?

Research has shown that radiofrequency microneedling, a treatment under study in this trial, effectively treats rosacea. Studies have found it reduces redness and the growth of unusual blood vessels, common in rosacea. People with mild-to-moderate rosacea have experienced noticeable improvements after this treatment. This method also promotes skin repair and new collagen growth, which can enhance skin texture for months. Overall, radiofrequency microneedling is considered a safe and effective way to manage rosacea symptoms. ^{2 3 6 7 8}

Who Is on the Research Team?

Ariel Eber, MD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

Adults over 18 with good health and diagnosed with erythematotelangiectatic or papulopustular rosacea can join this trial. They must understand and sign consent, be able to follow the study plan, and not use certain rosacea medications. People with skin conditions affecting diagnosis, poor wound healing, blood-clotting issues, extreme light sensitivity or a history of keloid scarring cannot participate.

Inclusion Criteria

I am over 18 and in good health.

I can understand and sign the consent form.

Subject is able to complete the study and comply with study procedures

Exclusion Criteria

Prisoners

I am currently using oxymetazoline or brimonidine.

A doctor has checked that skin conditions won't affect my cancer diagnosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Potassium titanyl phosphate (KTP) Laser Therapy with unilateral Radiofrequency Microneedling

36 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

16 weeks

What Are the Treatments Tested in This Trial?

Interventions

• KTP Laser Therapy
• Radiofrequency Microneedling

Trial Overview The trial is testing radiofrequency microneedling's effectiveness on two types of rosacea and its potential combined effect with KTP laser therapy. The goal is to find new treatment strategies for rosacea through these interventions.

How Is the Trial Designed?

Group I: Potassium titanyl phosphate (KTP) Laser Therapy with unilateral Radiofrequency Microneedling Experimental Treatment 2 Interventions

Participants will be in this group for up to 36 weeks

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

LUTRONIC Corporation

Industry Sponsor

Trials

15

Recruited

570+

Published Research Related to This Trial

The updated guidelines on rosacea, published in January 2022, introduce a new clinical classification based on different phenotypes, which helps in better diagnosing and treating the condition.

The guidelines also emphasize the importance of the gut microbiome in rosacea and include comprehensive recommendations for both approved and off-label therapies, as well as addressing the psychosocial impacts of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Rosacea-the updated S2k guideline]. Kuna, AC., Flaig, MJ., Guertler, A.[2023]

In a 12-week study involving a split-face trial on rosacea patients, fractional microneedling radiofrequency (FMR) treatment significantly reduced redness, with a 13.6% decrease in erythema index and a 6.8% decrease in a* value compared to baseline.

Histological analysis showed reduced inflammation and markers related to innate immunity and angiogenesis in the treated skin, suggesting that FMR may effectively improve rosacea symptoms and could be used alongside other treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and Histologic Effects of Fractional Microneedling Radiofrequency Treatment on Rosacea. Park, SY., Kwon, HH., Yoon, JY., et al.[2017]

In a 48-week study involving 34 patients with difficult-to-treat rosacea, non-insulated fractional microneedle radiofrequency (NFMRF) treatment significantly reduced the Clinical Erythema Assessment (CEA) score and Dermatology Life Quality Index (DLQI), indicating effective improvement in symptoms and quality of life.

The treatment was well-tolerated with no serious side effects reported, demonstrating that NFMRF can effectively improve rosacea symptoms while maintaining skin barrier integrity and patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of non-insulated fractional microneedle radiofrequency for treating difficult-to-treat rosacea: a 48-week, prospective, observational study. Wang, B., Deng, YX., Li, PY., et al.[2022]

In a study involving 30 patients with rosacea, radiofrequency (RF) therapy showed significant improvement in rosacea severity and lesion counts, particularly in those with papulopustular rosacea (PPR).

RF therapy was found to be as effective as pulsed dye laser (PDL) treatment for erythematotelangiectatic rosacea (ETR), but it provided superior results for reducing lesions in PPR, suggesting it could be a valuable alternative treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Efficacy of Radiofrequency and Pulsed Dye Laser in the Treatment of Rosacea. Kim, SJ., Lee, Y., Seo, YJ., et al.[2017]

Topical treatments like brimonidine, azelaic acid, and ivermectin, along with oral medications such as doxycycline and isotretinoin, have been shown to effectively improve rosacea symptoms based on high-quality evidence.

Most of these treatments do not lead to higher rates of adverse events compared to placebo, indicating they are generally safe options for patients with rosacea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions for Rosacea. van Zuuren, EJ., Fedorowicz, Z.[2018]

The study involved 16 patients with facial rosacea, and the use of a novel thermomechanical system (Tixel) to enhance skin permeability for botulinum toxin resulted in significant improvements in facial erythema and quality of life over 6 months, with all assessments showing P-values <0.001.

The treatment was found to be safe, with no reported side effects such as motor function impairment or drooping, and patients expressed high satisfaction with the results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The toxic edge-A novel treatment for refractory erythema and flushing of rosacea. Friedman, O., Koren, A., Niv, R., et al.[2020]

Fractional microneedling radiofrequency (FMR) is known to improve skin conditions like wrinkles and rosacea by promoting the production of new collagen and elastin, as well as reducing inflammation.

However, this case study of a 61-year-old woman revealed that FMR treatment led to the development of rosacea symptoms, highlighting a potential adverse effect that contradicts previous findings on the treatment's efficacy for rosacea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A case of fractional microneedling radiofrequency induced rosacea. Aşiran Serdar, Z., Aktaş Karabay, E.[2020]

Radiofrequency (RF) irradiation effectively reduces keratinocyte proliferation and the levels of pro-inflammatory cytokines, including VEGF, which are linked to the worsening of rosacea, based on both in vitro and in vivo studies.

RF irradiation significantly decreases blood vessel density in the skin of UVB-treated mice and rosacea patients, suggesting it may be a promising treatment option for managing rosacea symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiofrequency irradiation attenuates angiogenesis and inflammation in UVB-induced rosacea in mouse skin. Son, M., Park, J., Oh, S., et al.[2022]

Treatment with intradermal microdroplets of onabotulinumtoxinA showed anecdotal evidence of reducing symptoms like erythema and flushing in patients with rosacea, suggesting its potential efficacy for this condition.

No adverse events were reported during the treatments, indicating a favorable safety profile for onabotulinumtoxinA in managing rosacea symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new treatment regimen for rosacea: onabotulinumtoxinA. Dayan, SH., Pritzker, RN., Arkins, JP.[2018]

Effective management of rosacea requires a personalized treatment approach that considers individual symptoms, triggers, and patient preferences, emphasizing the importance of patient education.

Combining different clinical therapies to address various symptoms simultaneously may lead to better outcomes for patients with rosacea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rosacea: a Clinical Review. Mikkelsen, CS., Holmgren, HR., Kjellman, P., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06801717?cond=%22Rosacea%22&aggFilters=status:not%20rec%20enr%20act&viewType=Table&rank=3

Study Details | Rosacea Radiofrequency Microneedling There are 3 main objectives of this proposal as follows: (1) to assess the efficacy of radiofrequency microneedling in the treatment of erythematotelangiectatic ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33577211/

Radiofrequency Microneedling: A Comprehensive and ... Radiofrequency microneedling-induced dermal remodeling and neocollagenesis are slow and progressive but continue to improve even 6 months after ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1111/jocd.16354

Efficacy of fractional radiofrequency in the treatment of ... Conclusion. FRF for the treatment of erythematous capillary dilatation rosacea is effective, safe, and suitable for clinical promotion.

4. withpower.com withpower.com/trial/radiofrequency-microneedling-for-rosacea-8a5cd

Radiofrequency Microneedling for Rosacea Research shows that radiofrequency microneedling can reduce inflammation and abnormal blood vessel growth in rosacea, leading to improved symptoms. Additionally ...

5. healio.com healio.com/news/dermatology/20160909/fractional-microneedling-radiofrequency-used-as-rosacea-treatment

Fractional microneedling radiofrequency used as rosacea ... Patients with mild-to-moderate rosacea experienced modest clinical and histologic improvement following fractional microneedling radiofrequency treatment.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34196817/

Efficacy and safety of non-insulated fractional microneedle ... No serious side effects were observed. NFMRF alone results in visible improvement and has great efficacy for difficult-to-treat rosacea without ...

7. dermatologytimes.com dermatologytimes.com/view/fda-alerts-clinicians-to-serious-complications-with-radiofrequency-microneedling-devices

FDA Alerts Clinicians to Serious Complications with ... Providers should be aware of the potential for significant tissue injury with RF microneedling, especially in cosmetically sensitive or ...

8. vogue.com vogue.com/article/radiofrequency-microneedling-fda-safety-warning

How Safe Is Radiofrequency Microneedling, Really? “The dangers include pain, bleeding, swelling, bruising, and infection. Longer term risks include burns, scars, never damage, discoloration ( ...