Evaluation of the Efficacy of a Serum Containing Niacinamide, Tranexamic Acid, Vitamin C, and Hydroxy Acid Compared to 4% Hydroquinone in the Management of Melasma.

Introduction: Melasma is a common skin condition that remains challenging to treat. Hydroquinone at 4% (HQ4%) is a frequently prescribed depigmenting compound that has been associated with potential side effects.

Objective: This study assessed the benefit in melasma of an anti-hyperpigmentation serum (Serum B3 containing 5% niacinamide, 1% tranexamic acid, 0.2% of a stabilized form of vitamin C, and different hydroxy acids) compared to HQ4%.

Materials And Methods: In a single-site, investigator-blind, randomized study, 60 females aged between 20 and 50 years with facial melasma received Serum B3 for 5 months (Group 1) or HQ4% for 3 months followed by Serum B3 for an additional2 months (Group 2). Endpoints were Melasma Area and Severity Index (MASI), modified MASI (mMASI), Investigational Global Assessment, erythema, clinical cutaneous parameters, and safety. Subjects assessed quality of life (QoL) and cosmetic acceptability. Confocal reflecting microscopy was performed.

Results: A significant (p < 0.001) reduction in pigmentation was seen in both groups after 3 months. A higher erythema score was noted in Group 2. Hydration and skin barrier function performed better in Group 1. QoL significantly (p < 0.001) improved in both groups after 84 days. Serum B3 was tolerated better than HQ, and subjects appreciated Serum B3. Melanin density reduction was similar for both groups after 3 and 5 months.

Conclusion: Serum B3 used for 5 months and HQ4% applied for 3 months, followed by a 2-month use of Serum B3, had a similar efficacy profile, with Serum B3 having a better local tolerance and patient acceptability.