Comparative Efficacy and Safety of Oral Tranexamic Acid, 1% Arbutin Cream, and Their Combination in the Treatment of Melasma in Sulaymaniyah City: A Randomized Controlled Trial

Volume 15 , Issue 2 , December 2025 , Pages 108-120

Authors

Hanaa Jaafar Hama Rashid 1 ; Darsim Mohammed Abdalla 2

1 Sulaimani Directory of Health, Sulaiamni, Kurdistan Region, Iraq

2 Department of Clinical Science, College of Medicine, University of Sulaiamni, Kurdistan Region, Iraq

DOI logo 10.17656/jsmc.10496

Keywords

Abstract

Background: Melasma is a prevalent acquired pigmentary disorder, often affecting women with Fitzpatrick skin types III-VI. Despite various treatment modalities, achieving complete resolution remains challenging due to frequent recurrences. This study evaluates the efficacy and safety of oral tranexamic acid (TXA), topical 1% arbutin cream, and their combination, addressing gaps in long-term therapeutic strategies.

Patients and Methods: This open-label RCT, conducted at the Shahid Jabar Dermatology Center in Sulaymaniyah (Dec 2024–Jun 2025), included 120 melasma patients. They were randomized into three groups: Group A (oral TXA), Group B (topical 1% arbutin), and Group C (both). Melasma severity was assessed at baseline, 1, 2, and 3 months. Patient satisfaction was measured with a 5-point Likert scale, and adverse effects were monitored. Follow-up lasted 3 months after treatment discontinuation.

Results: Baseline mMASI scores were similar across groups. After 3 months, Group C showed the greatest reduction (4.25 ± 2.13), followed by Group A (5.70 ± 3.15) and Group B (5.96 ± 2.99). Group C had the highest patient satisfaction (42.5%) and the lowest recurrence rate (14%). Adverse effects were minimal: epigastric pain in Groups A (20%) and C (17.5%), and skin irritation in Group B (2.5%). Group C also demonstrated significantly better outcomes compared to Group B (P = 0.007).

Conclusion: Combination therapy with oral TXA and topical arbutin showed greater efficacy, higher satisfaction, and lower recurrence rates than monotherapy, providing a more durable solution for melasma. Further research is needed to optimize long-term outcomes.

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  • First online21 December 2025
  • Published at21 December 2025

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