Evaluation of therapeutic efficacy of tranexamic acid compared to modified Kligman formula in the management of melasma

Background: Facial melanoses (FM) are a common presentation in Indian patients, causing cosmetic disfigurement with considerable psychological impact. Melasma is an acquired non-inflammatory hypermelanosis of multifactorial etiology with significant cosmetic deformity. Different treatment modalities have been tried in different studies with varying outcomes. Recent clinical trials with tranexamic acid (TXA) are promising. Objective: To compare the therapeutic efficacy of TXA topical application after micro-needling and intralesional TXA with the modified Kligman formula in the management of melasma. Materials and Methods: This is a prospective, randomized, open-label study with a sample size of 45 patients with melasma fulfilling inclusion and exclusion criteria. They were randomly divided into three groups of 15 each. Group A individuals were advised to apply a modified Kligman formula daily at night for 3 months, Group B individuals weekly micro-needling followed by TXA application for 3 months, and Group C individuals intralesional TXA (4 mg/mL) weekly for 3 months. Clinical and dermoscopic images were taken at each visit, including modified Melasma Area Severity Index (MASI) scoring, patient global assessment, and physician global assessment to assess the clinical response. Results: Group A showed a 42% improvement in MASI score by the end of 12 weeks, Group B showed a 30% improvement, and Group C showed a 36% improvement. When statistically compared with the Analysis of Variance test, there was no significant difference (P = 0.62) between the three groups. However, in individual groups, there was a significant difference (P < 0.05) in MASI at 0 and 12 weeks. Dermoscopic images showed perilesional hypopigmentation and telangiectasias with a modified Kligman formula, which was not seen with TXA. Patient assessment score revealed satisfaction with the modified Kligman formula because of home application and lack of pain. Conclusion: The modified Kligman formula is found to be superior in the treatment of melasma, because of the synergistic activity of its components. However, it has its demerits of long-term usage like hypopigmentation and telangiectasias. Hence, TXA that showed comparable results with the Kligman formula can be used either as a primary modality or as an adjuvant supportive therapy for maintenance.