Microneedling-Assisted Metformin, Tranexamic Acid, and Modified Kligman's Formula for Melasma

Melasma is a common skin condition characterized by brown or gray patches on sun-exposed areas of the face. Although several topical treatments are available, treatment outcomes are often unsatisfactory, and recurrence is common. This randomized, parallel-group clinical trial aims to compare the efficacy and safety of microneedling-assisted topical metformin, topical tranexamic acid, and modified Kligman's formula with microneedling-assisted saline in adult women with melasma. Eighty participants will be randomly assigned to one of four treatment groups. The primary outcome is the change in Melasma Area and Severity Index (MASI) score from baseline to the end of follow-up. Secondary outcomes include clinical improvement, dermoscopic changes in pigmentation and vascular features, patient satisfaction, and treatment-related adverse events.

NCT Number	NCT07696806
Lead Sponsor	Sameh Sarsik
Conditions	Melasma (Facial Melasma)
Enrollment	80 participants
Start Date	2026-07-10
Primary Completion	2027-06-30 (estimated)
Study Completion	2027-08-30 (estimated)
Updated on ClinicalTrials.gov	2026-07-28