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.
Summary
In a randomized, investigator-blind trial (n=60), a niacinamide–tranexamic acid–vitamin C–hydroxy acids serum achieved comparable melasma improvement to 4% hydroquinone at 3–5 months. The serum showed better tolerability (less erythema) and superior skin hydration/barrier metrics, with significant QoL gains in both groups.
Key Findings
- Both groups had significant pigmentation reduction at 3 months (p<0.001).
- Higher erythema scores in the hydroquinone-first group; better hydration and barrier function with the serum.
- Quality of life improved significantly in both groups by day 84.
- Melanin density reduction by confocal reflectance microscopy was similar between regimens at 3 and 5 months.
- Serum B3 exhibited better local tolerability and cosmetic acceptability.
Clinical Implications
Consider multi-ingredient serum as first-line or maintenance therapy for melasma in patients intolerant to hydroquinone or where HQ use is restricted; monitor erythema and skin barrier metrics to tailor regimens.
Why It Matters
Provides randomized evidence supporting a non-hydroquinone alternative with comparable efficacy and improved tolerability, addressing safety concerns and regulatory limitations around hydroquinone.
Limitations
- Single-site study with modest sample size (n=60).
- Short-to-intermediate follow-up (3–5 months) without long-term relapse data.
Future Directions
Conduct multicenter, double-blind RCTs with longer follow-up and diverse skin phototypes to assess durability, relapse, and optimal sequencing/maintenance.
Study Information
- Study Type
- RCT
- Research Domain
- Treatment
- Evidence Level
- II - Single-site, investigator-blind randomized controlled trial with n=60.
- Study Design
- OTHER