Radiofrequency Microneedling for Melasma

(SylfirmX Trial)

Overseen By Rothy Rim

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Cleveland Clinic

Must not be taking: Topicals, Oral therapy

Disqualifiers: Pregnancy, others

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

Compensation: Varies

Number of Visits: 8

Duration: 5 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test whether radiofrequency microneedling, a skin treatment using tiny needles and heat, can effectively treat melasma, a condition causing dark patches on the skin, particularly in people with darker skin tones. Participants will receive five treatments over five months to determine if their skin condition improves. The trial seeks individuals with darker skin (Fitzpatrick skin types IV-VI) who have been diagnosed with melasma and have not used certain skincare products, such as retinol or vitamin C, for at least six weeks. As an unphased trial, this study offers a unique opportunity to explore a promising treatment option for melasma.

Will I have to stop taking my current medications?

The trial requires that you stop using any topical or oral treatments for melasma before participating.

What prior data suggests that radiofrequency microneedling is safe for treating melasma?

Studies have shown that radiofrequency microneedling (RFMN) is generally safe for treating skin conditions like melasma. Research indicates a low risk of scarring or changes in skin color, even for individuals with darker skin tones. One study found that RFMN can maintain melasma improvements without serious side effects. Additionally, microneedling RF is considered safe for enhancing skin texture, suggesting it could be a reliable option for melasma. Overall, evidence supports that RFMN is well-tolerated and effective for skin treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Radiofrequency Microneedling (RFMN) is unique because it combines two technologies—radiofrequency energy and microneedling—to specifically target melasma, a condition characterized by dark, discolored patches on the skin. Unlike traditional treatments like topical creams or chemical peels, which primarily address surface pigmentation, RFMN penetrates deeper layers of the skin, aiming to improve melasma by stimulating collagen production and promoting skin renewal from within. Researchers are excited about this treatment because it offers a potentially more effective and longer-lasting solution with minimal downtime, especially for patients with skin of color who often face challenges with typical treatments.

What evidence suggests that radiofrequency microneedling is effective for melasma?

Research has shown that radiofrequency microneedling (RFMN) may help treat melasma, a condition causing dark spots on the skin. Studies have found that microneedling can significantly enhance treatment outcomes, especially when combined with other therapies. Radiofrequency, in particular, targets the deeper skin layers, aiding in the improvement of melasma spots. One study found that most patients experienced reduced skin redness and increased confidence after treatment. These findings suggest that RFMN could be a beneficial option for managing melasma, particularly for individuals with darker skin tones. Participants in this trial will undergo five consecutive RFMN treatments over five months to evaluate its effectiveness specifically for skin of color patients with melasma. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with clinically diagnosed melasma, specifically those with darker skin types (IV-VI according to the Fitzpatrick scale). Participants must not have used certain skin treatments like retinol or vitamin C serum for six weeks prior, except sunscreen.

Inclusion Criteria

My skin type is classified as IV, V, or VI according to the Fitzpatrick scale.

I have been diagnosed with melasma.

I haven't used any skin products except sunscreen for 6 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive 5 consecutive RFMN treatments over a period of 5 months

5 months

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Radiofrequency Microneedling

Trial Overview The study is testing radiofrequency microneedling (RFMN) as a potential treatment for melasma in people with darker skin tones. The goal is to see if RFMN can effectively reduce hyperpigmentation caused by melasma.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

The target population is skin of color patients with melasma. Patients will receive 5 consecutive RFMN treatments over a period of 5 months.

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

Benev Company, Inc.

Industry Sponsor

Trials

3

Recruited

130+

Published Research Related to This Trial

Microneedles (MNs) have gained popularity in cosmetics, but their safety profile is still being established as the FDA begins to regulate these devices.

Current literature indicates that while MNs are widely used, there is a need for more research to fully understand potential adverse effects, such as infections and skin reactions, associated with their use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dermatotoxicology of microneedles (MNs) in man. Cary, JH., Li, BS., Maibach, HI.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11680975/

Review of Applications of Microneedling in Melasma - PMC Microneedling has tremendous potential for treating melasma. Microneedling can significantly improve treatment outcomes, especially when paired with additional ...

2. nature.com nature.com/articles/s41598-023-51133-w

Targeting the dermis for melasma maintenance treatment In conclusion, the microneedling RF therapy appears to be beneficial in combination with the conventional therapy of melasma, suggesting the ...

3. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/11/NCT06616311/Prot_001.pdf

Research Protocol guidelines for Investigators/ ... Objectives. The objective of this study is to test the effectiveness of radiofrequency microneedling (RFMN) as a treatment for melasma.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9209614/

A Pilot Study - PMC - PubMed Central Radiofrequency has been shown to produce dermal changes in melasma lesions, whereas polynucleotides have been investigated for antimelanogenesis ...

5. jcadonline.com jcadonline.com/efficacy-radiofrequency-tolerability-microneedling/

An Open-label Study Assessing the Efficacy and ... Following skincare protocol application, most subjects (97%) observed improvements in skin redness and/or treatment site marks, felt more confident (90%) and ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36826381/

A Review of Usage, Safety, and Efficacy Conclusion: Radiofrequency and RFM seem to have a low risk of scarring or hyperpigmentation in skin of color. This review demonstrates that ...

7. link.springer.com link.springer.com/article/10.1007/s13555-022-00728-8

Efficacy and Safety of Using Noninsulated Microneedle ... Microneedling RF may be considered as safe and efficacious for the improvement of skin roughness, and as an adjunctive treatment option for ...

8. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jocd.16661

Efficacy and Safety of Combination Therapy ... This study aims to evaluate the efficacy and safety of combining radiofrequency microneedling (RFM) with Cysteamine cream, applied both in-office and as a part ...