Efficacy of Tranexamic acid Microneedling versus Intradermal Injection of Tranexamic Acid in the Treatment of Melasma – A Randomised Controlled Trial

Abstract Background: Melasma is a pigmentary disorder that typically appears on the face. Given its tendency to relapse, resistance to treatment and significant impact on social and emotional well-being, melasma poses considerable challenges. Objectives: To compare the effectiveness and adverse effects of tranexamic acid (TXA) in reducing modified Melasma Area and Severity Index (mMASI) scores when given along with microneedling versus intradermal injections in the treatment of melasma. Materials and Methods: This was a hospital-based randomised controlled study conducted in the outpatient Department of Dermatology, Venereology and Leprosy, Aarupadai Veedu Medical College, among patients with melasma, between November 2022 and April 2024. In Group A ( n = 35), patients received microneedling with TXA (4 mg/mL) and intradermal injections of TXA (4 mg/mL) in Group B ( n = 35). Treatment was administered every 4 weeks for four sessions and followed-up once a month for 2 months. Results: The baseline characteristics of the study groups did not vary significantly by age (in years), gender, Fitzpatrick skin type, precipitating factors, clinical type of melasma, and pattern of melasma. Both groups showed significant reduction in mMASI scores from baseline to 20 weeks (7.1 ± 2.3 to 4.6 ± 0.5 in Group A and 7.0 ± 3.1 to 5.3 ± 0.7 in Group B, respectively). From 12 th week onwards, Group A had significantly lower mMASI scores than Group B ( P < 0.05). A total of 83% of Group A patients had nearly cleared melasma compared to 37.0% in Group B ( P < 0.05). Photographic documentation revealed that over 75.0% of Group A patients had more than 50.0% improvement, against 40.0% in Group B ( P < 0.05). Adverse events such as erythema, pain, burning sensation, and pigmentation were slightly more common in Group B, but the difference was not statistically significant. Conclusion: The study highlights microneedling with TXA as a promising and effective treatment option for melasma, offering substantial clinical improvement and patient satisfaction.