A randomized, open label study of two different dosage regimens of oral tranexamic acid in the treatment of moderate to severe melasma

Melasmais a common, acquired disorder of hyperpigmentation affecting millions ofpeople worldwide. It causes tremendous impact on the self esteem and quality oflife of the affected people, especially females. While various topical agentshave so far been the mainstay of treatment of melasma, they are plagued by sideeffects as well relapse and recurrences omce they are stopped. Oral tranexemicacid (TXA) is the latest tool in the armamentarium of melasma treatment. It hasso far been used in various forms including oral, topical and injectable withvariable but promising results. However, the dosingof TXA in melasma has been a cause of persistent speculation and this puzzle iswhat our study aims to shed some light on. Doses of TXA used for melasma instudies to date have ranged from 500 to 1,500mg daily.45 A typicaldose is 250 mg twice daily. Treatment is usually continued for 8 to 12 weeks.45This is in contrast to menorrhagia for which the dose is 3.9 to 4 g daily forup to 5 days per month.34 However, there is still no consensus toguide the dose and duration of therapy. There is also not much clarity on therisk of relapse after stopping oral TXA and if maintenance treatment isrequired and if so, if the duration of maintenance regimen differes withdifferent dosages of TXA. Studies have documented safe useof TXA formenorrhagia over the years with only minor side effects like nasal and sinusdiscomfort, back pain, musculoskeletal pain, oligomenorrhea, and abdominalcramps, with no evidence of ocular toxicity.22, 34, 35 Hence, at the dosages currently employed  and based on available data, it seems unlikelythat TXA would increase risk of thrombotic complications, more so in theindications for which it is used in dermatology.

The present study is designed as a randomized, openlabel study in which 50 patients suffering from moderate to severe melasmaaccording to the mMASI scores will be recruited and be divided into two arms toreceive oral tranexemic acid at a dose of 250 mg twice a day or 500 mg twice aday for 12 weeks along with a sunscreen of SPF 30+.  Theprimary objective is to evaluate and compare the efficacy of the two differentdosing regimens of TXA, that is, 250 mg twice daily versus 500 mg twice daily, usingthe mMASI score. The proportion ofpatients achieving mMASI 75 will be used as the proxy measure to assess theefficacy. The secondary aims will include assessing the MELASQOL score of thepatients at baseline and the end of treatment to have an objective analysis ofthe impairment of quality of life caused by melasma, apart from noting any adverseeffects, if any.