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

NCT ID: NCT06616311

Last Updated: 2026-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Melasma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Radiofrequency microneedling (RFMN) as a treatment for melasma
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

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

Group Type EXPERIMENTAL

Radiofrequency microneedling

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Benev Company, Inc.

INDUSTRY

Sponsor Role collaborator

The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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Shilpi Khetarpal

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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23-649

Identifier Type: -

Identifier Source: org_study_id

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