Efficacy of Radiofrequency Micro Needling for the Treatment of Melasma in Skin of Color. (SylfirmX)

February 5, 2026 updated by: Shilpi Khetarpal, The Cleveland Clinic

A Prospective Study of the Efficacy of Radiofrequency Micro Needling for the Treatment of Melasma in Skin of Color.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The target population is skin of color patients with melasma. Patients will receive 3 consecutive RFMN treatments over a period of three months. Baseline melasma severity will be measured by the modified Melasma Area and Severity Index (mMASI) score. Endpoints will be mMASI scores at 1 and 3 months post-procedure. Patient reported outcomes will be measured using the melasma quality of life (MelasQOL) validated patient questionnaire at screening and at both follow up visits. The long-term goal of future studies would be to provide melasma patients, particularly those with skin of color, with improved therapeutic options for the treatment of their melasma, as compared to current treatment options.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Males or females, at least 18 years of age
  • Fitzpatrick skin types IV-VI
  • Clinically diagnosed melasma
  • No topicals (retinol, vitamin C serum, etc) for 6 weeks before Visit 1 (with exception of sunscreen)

Exclusion Criteria:

  • is currently pregnant or planning to conceive during the study period
  • is using topical or oral therapy or other treatment for melasma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
The target population is skin of color patients with melasma. Patients will receive 5 consecutive RFMN treatments over a period of 5 months.
Device: Radiofrequency microneedling
The target population is skin of color patients with melasma. Patients will receive 5 consecutive RFMN treatments over a period of 5 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment efficacy as determined by change in mMASI scoring of melasma severity post-treatment.
Time Frame: 9 months
The primary endpoint is treatment efficacy as determined by change in mMASI scoring of melasma severity post-treatment.
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Collaborators

Benev Company, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2024

Primary Completion (Actual)

December 31, 2025

Study Completion (Actual)

December 31, 2025

Study Registration Dates

First Submitted

September 25, 2024

First Submitted That Met QC Criteria

September 26, 2024

First Posted (Actual)

September 27, 2024

Study Record Updates

Last Update Posted (Actual)

February 9, 2026

Last Update Submitted That Met QC Criteria

February 5, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-649

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe