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Safety and efficacy of niosomal and conventional tranexamic acid/niacinamide vs. hydroquinone creams in melasma: A randomized, double-blind, case-controlled clinical trial
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Safety and efficacy of niosomal and conventional tranexamic acid/niacinamide vs. hydroquinone creams in melasma: A randomized, double-blind, case-controlled clinical trial
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Safety and efficacy of niosomal and conventional tranexamic acid/niacinamide vs. hydroquinone creams in melasma: A randomized, double-blind, case-controlled clinical trial
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Journal Article
Safety and efficacy of niosomal and conventional tranexamic acid/niacinamide vs. hydroquinone creams in melasma: A randomized, double-blind, case-controlled clinical trial
2025
Overview
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).
Publisher
Nature Publishing Group UK,Nature Publishing Group,Nature Portfolio
Subject
/ 692/308
/ 692/699
/ 692/700
/ Acids
/ Adult
/ Female
/ Humanities and Social Sciences
/ Humans
/ Hydroquinones - administration & dosage
/ Hydroquinones - adverse effects
/ Hydroquinones - therapeutic use
/ Male
/ Melanin
/ Melasma
/ Niosome
/ Patients
/ Science
/ Skin Cream - administration & dosage
/ Tranexamic Acid - administration & dosage
/ Tranexamic Acid - adverse effects
