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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
The target population is skin of color patients with melasma. Patients will receive 5 consecutive RFMN treatments over a period of 5 months.
Cleveland Clinic
Cleveland, Ohio, United States
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.
Time frame: 9 months
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