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

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06616311

Acronym

SylfirmX

Enrollment

Registered

2024-09-27

Start date

2024-10-01

Completion date

2025-12-31

Last updated

2026-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melasma

Brief summary

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.

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.

Interventions

DEVICERadiofrequency microneedling

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Radiofrequency microneedling (RFMN) as a treatment for melasma

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026