Sci Rep. 2025 Nov 28;15(1):42739. doi: 10.1038/s41598-025-26693-8.
ABSTRACT
Melasma is a common hyperpigmentary skin disorder. Because of its high prevalence and serious complications, including negative psychiatric effects, early diagnosis and treatment would be essential. This randomized, double-blind, case-controlled clinical trial compared the efficacy of niosomal tranexamic acid (TXA) 2%/niacinamide (NCA) 2% cream and conventional TXA 5%/NCA 4% cream with topical hydroquinone (HQ) 4% cream as a gold standard in melasma patients. A total of 99 patients were randomly assigned to three groups: Group A received niosomal TXA/NCA cream, Group B received conventional TXA/NCA cream, and Group C received HQ cream for three months. Each patient attended five dermatologist visits to evaluate clinical efficacy. All treatment groups showed a considerable reduction in melanin index and modified melasma area and severity index (mMASI) scores, as well as a notable improvement in patients’ quality of life. Although both niosomal TXA/NCA cream and conventional TXA/NCA cream were as effective as HQ cream in management of melasma, adverse reactions and relapse were observed in HQ group. Niosomal or conventional TXA/NCA creams are as effective as HQ 4% cream and due to less serious adverse reactions they would be better choices than HQ-containing preparations in hyperpigmentary disorders. Clinical Trial Registration No.: IRCT20220609055116N1 (Approval date: 07/23/2023).
PMID:41315336 | DOI:10.1038/s41598-025-26693-8
