Efficacy of oral tranexamic acid versus triple combination for the treatment of melasma: A prospective, double blinded randomised controlled trial

Abstract

Melasma is a common acquired hypermelanosis characterized by irregular light to dark brown macules and patches seen mainly in women and over sun-exposed skin on the face. We have undertaken this RCT to compare the efficacy between oral Tranexamic acid and Topical Triple combination as Tranexamic acid is having good safety profile.To compare the therapeutic efficacy of oral Tranexamic acid versus Topical Triple combination for the treatment of Melasma using MASI score. To compare the adverse effects profile of each treatment modality. Total subjects (66 patients) were divided into 2 groups (A and B, each with 33 patients) by simple randomization method.Patients and analysers were blinded to treatments. Group-A received topical triple combination cream once daily (15-minutes) at night for 8 weeks followed by maintenance regimen of biweekly application of product for 4 weeks and oral placebo tablets (calcium gluconate 250mg) twice daily for 12 weeks. Group-B received oral Tranexamic acid tablets 250mg twice daily for 12 weeks with topical placebo cream (Moisturizer) once daily at night for 8 weeks followed by maintenance regimen of biweekly application of product for 4 weeks. MASI score was assessed at baseline and monthly follow-up visits along with simultaneous serial digital photographs, with the recording of side effects. Both groups showed significant decrease in MASI score in each followup visits without any statistically significant difference.In epidermal melasma topical triple combination is preferred over oral tranexamic acid. In dermal and mixed variety oral tranexamic acid is better.