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

10 Participants Needed

Trial Summary

What is the purpose of this trial?

The objective of this study is to test the effectiveness of radiofrequency microneedling (RFMN) as a treatment for melasma. The Investigator hypothesize that RFMN will be an effective treatment for melasma in skin of color patients.

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 data supports the effectiveness of the treatment Radiofrequency Microneedling for Melasma?

Research shows that microneedling, especially when combined with radiofrequency, has been used effectively for skin conditions like scars and pigmentation issues, which are similar to melasma. Studies suggest that this treatment can help improve melasma by enhancing skin rejuvenation and reducing pigmentation. ^{1 2 3 4 5}

Is radiofrequency microneedling safe for humans?

Radiofrequency microneedling is generally considered safe for humans, with minimal side effects such as redness, pain, swelling, and temporary skin irritation. It is important for both clinicians and patients to be aware of these potential side effects to minimize risks. ^{3 4 6 7 8}

How is radiofrequency microneedling different from other treatments for melasma?

Radiofrequency microneedling is unique because it combines radiofrequency energy with microneedles to treat melasma, potentially improving skin penetration and rejuvenation. Unlike some laser treatments that require many sessions, this method may offer effective results with fewer treatments and a lower risk of skin discoloration after the procedure. ^{1 3 4 5 7}

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Using Noninsulated Microneedle Radiofrequency Alone Versus in Combination with Polynucleotides for the Treatment of Melasma: A Pilot Study. [2022]

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

Microneedling as an adjuvant to topical therapies for melasma: A systematic review and meta-analysis. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Can Microneedle Fractional Radiofrequency System Treatment Impair the Skin Barrier Function in Chinese Patients? A Prospective Clinical Trial. [2022]

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

A Systematic Review of the Efficacy and Safety of Microneedling in the Treatment of Melasma. [2021]

5. Korea (South) pubmed.ncbi.nlm.nih.gov

A Face-Split Study to Evaluate the Effects of Microneedle Radiofrequency with Q-Switched Nd:YAG Laser for the Treatment of Melasma. [2022]

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

Dermatotoxicology of microneedles (MNs) in man. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Microneedling with cutaneous delivery of topical agents for the treatment of melasma: A systematic review. [2022]

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

A Systematic Review Examining the Potential Adverse Effects of Microneedling. [2021]