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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.

Journal of cosmetic dermatology2025-03-10PubMed
Total: 69.5Innovation: 7Impact: 6Rigor: 8Citation: 5

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