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

NCT06616311 | Completed FDA Device

• 1 other identifier: 23-649
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Melasma

Outcome Measures

Primary Outcomes (1)

• Treatment efficacy as determined by change in mMASI scoring of melasma severity post-treatment.

  The primary endpoint is treatment efficacy as determined by change in mMASI scoring of melasma severity post-treatment.

  9 months

Study Arms (1)

Treatment

EXPERIMENTAL

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

Interventions

Radiofrequency microneedling DEVICE

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

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Benev Company, Inc.: collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Melanosis

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Radiofrequency microneedling (RFMN) as a treatment for melasma

Study Record Dates

• First Submitted: September 25, 2024
• First Posted: September 27, 2024
• Study Start: October 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 9, 2026

Record last verified: 2025-12

Locations

US (1)