The plain-language read
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.
- 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.
- 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.
- 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.
Relevant if you're working with niacinamide, tranexamic acid, hydroquinone for hyperpigmentation.
What this means for your routine
If you're targeting hyperpigmentation, this research supports adding niacinamide to your AM/PM routine. Effective concentration range: 2% based on this study.
If you're targeting hyperpigmentation, this research supports adding tranexamic_acid to your AM/PM routine. Effective concentration range: 2% based on this study.
Translated from this study's findings, not a personal prescription. Pair with your existing protocol and your practitioner's guidance.
Technical Summary, For Professional Reference
Clinical context
1. Sci Rep. 2025 Nov 28;15(1):42739. doi: 10.1038/s41598-025-26693-8. Safety and efficacy of niosomal and conventional tranexamic acid/niacinamide vs. hydroquinone creams in melasma: A randomized, double-blind, case-controlled clinical trial. Ghasemiyeh P(1), Haghighi NF(2)(3), Dastgheib L(2)(3), Ranjbar S(2)(3), Mohammadi-Samani S(4)(5).
Full abstract→
1. Sci Rep. 2025 Nov 28;15(1):42739. doi: 10.1038/s41598-025-26693-8. Safety and efficacy of niosomal and conventional tranexamic acid/niacinamide vs. hydroquinone creams in melasma: A randomized, double-blind, case-controlled clinical trial. Ghasemiyeh P(1), Haghighi NF(2)(3), Dastgheib L(2)(3), Ranjbar S(2)(3), Mohammadi-Samani S(4)(5). Author information: (1)Pharmaceutical Sciences Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. (2)Molecular Dermatology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. (3)Department of Dermatology, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran. (4)Pharmaceutical Sciences Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. smsamani@sums.ac.ir. (5)Department of Pharmaceutics, School of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran. smsamani@sums.ac.ir. 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). © 2025. The Author(s). DOI: 10.1038/s41598-025-26693-8 PMCID: PMC12663283 PMID: 41315336 [Indexed for MEDLINE] Conflict of interest statement: Declarations. Competing interests: The authors declare no competing interests. Ethics declarations: This study was performed according to the principles of the Declaration of Helsinki. Approval was granted by the Ethics Committee of the Shiraz University of Medical Sciences [Ethics Approval ID: IR.SUMS.REC.1402.050] and Iranian Registry of Clinical Trials (IRCT) [IRCT Approval ID: IRCT20220609055116N1, approval date: 07/23/2023]. The full clinical trial protocol can be find through https://irct.behdasht.gov.ir/trial/67780 . Consent to participate: Informed consent was obtained from all participants and/or their legal guardians. Consent to publish: Informed consent was obtained from all participants to publish the information/images in an online open access publication.
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