Reduction in facial hyperpigmentation after treatment with a combination of topical niacinamide and tranexamic acid: a randomized, double-blind, vehicle-controlled trial.

BACKGROUND: Facial hyperpigmentation occurs in multiple conditions. In addition, many Asian women desire a lighter skin color. Thus, there is a need for the development of skin lightening agents, and niacinamide and tranexamic acid (TXA) are promising candidates. OBJECTIVE: To assess the effectiveness of a combination of niacinamide and TXA as a topical moisturizing formulation for treatment of irregular facial pigmentation. MATERIALS AND METHODS: A total of 42 Korean women (age range: 30-60 years) who were not pregnant, nursing, or undergoing any concurrent therapy were enrolled in this study for 8 weeks. Subjects used a twice-daily regimen of either a moisturizing cream containing 2% niacinamide + 2% TXA (test formulation; n = 21) or cream vehicles (vehicle control; n = 21) in addition to an assigned sunscreen each morning. Pigmentation was measured objectively using a mexameter and chromameter, in addition to physicians' assessment using clinical photographs. RESULTS: The niacinamide + TXA formulation regimen was significantly (P < 0.05) more effective than the vehicle control formulation regimen in reducing the appearance of pigmentation. CONCLUSION: A formulation containing the combination of niacinamide + TXA reduced the appearance of irregular pigmentation, providing an effect beyond that achieved with sunscreen.