Efficacy of a depigmenting serum containing tranexamic acid + niacinamide + 4-butylresorcinol and hydroxy acids complex compared to hydroquinone in the treatment of melasma: a randomized, double-blind, comparative clinical trial

BACKGROUND: Melasma is a common hyperpigmentary disorder. Hydroquinone is widely used to treat melasma, but its use may be limited by adverse effects. Topical tranexamic acid (TXA), alone or combined with other agents, is a potential alternative.
OBJECTIVES: To evaluate the noninferiority of a new quadruple combination (QC) containing 3% TXA, niacinamide, 4-butylresorcinol and a hydroxyacid complex compared with 4% hydroquinone (HQ4) in the treatment of melasma.
METHODS: Eighty participants with melasma were included and randomly assigned to 2 groups: QC and HQ4. The study duration was 120 days. Efficacy criteria include mMASI, colorimetry (ITA and L*) and MELASQOL.
RESULTS: There was a significant improvement in mMASI, ITA, L* and MELASQOL in both groups (p<0.05) with no statistical difference (p>0.05) between them, indicating the noninferiority of QC serum compared with HQ4. Notably, the new serum showed greater improvements in mMASI, ITA and L* at D30 compared with HQ4, suggesting a greater initial response to treatment.
CONCLUSION: The new QC serum demonstrated non-inferiority to HQ4 after 12 weeks of treatment. In addition, its benefits were maintained for 4 weeks after treatment discontinuation. QC serum may represent a safe and effective alternative to HQ4 in the treatment of facial melasma.

Keywords: Hyperpigmentation; Melanosis; Tranexamic Acid; Niacinamide