Clinical study on efficacy, safety and mechanisms of action of microneedleing and oral tranexamic acid in the treatment of facial melasma

Abstract

Introduction: Until now, there are no treatments for melasma which are highly efficient or present satisfactory results. Objectives: To evaluate efficacy and security of two sessions of microneedling (1,5mm), of tranexamic acid oral use (250mg, 2x/day for 60 days) and the combination of them in treatment for facial melasma in women. Method: Pilot study: 20 women with facial melasma; 10 of them will undergo microneedling (1,5mm needles) and a biopsy will be taken (punch 3mm) of the facial melasma area. After one week (T7), the same group of women will be re-evaluated and a new biopsy will be taken. The other group of women will be photographed and observed without any intervention. Biopsy fragments will be stained. Main Project: randomized factorial clinical trial. 64 adult women with facial melasma will be randomly put in four different treatment groups: (GC) current standard treatment (sunscreen and triple formula); (GM) standard treatment, microneedling and oral placebo; (GMT) standard treatment, microneedling and oral tranexamic acid; (GT) standard treatment and oral tranexamic acid. From the 60th day on, the 64 women group will keep standard treatment. Participants will be clinically evaluated in T0, T60 and T120. We will take biopsy of the facial melasma area and special stains will be tested in T0 e T60. Expecting Results: To quantify and clarify microneedling and oral tranexamic acid effects as adjuvants in treatment for melasma, as well as the maintenance of results after suspending therapeutical methods and maintenance with sunscreen and triple formula of night use at home. (AU)