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.

Inclusion Criteria: * Female participants aged 18 years or older. * Clinical diagnosis of melasma. * No medical treatment for melasma during the previous 6 months. * Willing and able to comply with all study procedures and follow-up visits. * Provided written informed consent before study participation. Exclusion Criteria: * Pregnant or breastfeeding women. * Use of hormonal contraceptives. * Use of medications known to affect skin pigmentation (e.g., phenytoin, amiodarone, antipsychotics, cytotoxic agents, tetracyclines, or heavy metals). * History of keloid formation or foreign body reaction. * Known allergy or hypersensitivity to any study medication. * Presence of systemic diseases affecting pigmentation, including hepatic, renal, thyroid, or other endocrine disorders. * Fitzpatrick skin types V or VI.