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

Not Applicable

Active, not recruiting

• Conditions: Melasma
• Interventions: Device: Radiofrequency microneedling

• Registration Number: NCT06616311
• Lead Sponsor: The Cleveland Clinic

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.

Study Timeline

• Study First Submitted: 2024-09-25
• Study First Submitted QC: 2024-09-26
• Study First Posted: 2024-09-27
• Study Start: 2024-10-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-06
• Last Update Posted: 2025-01-07
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States