Evaluation of Therapeutic Efficacy and Safety of Tranexamic Acid Local Infiltration in Combination with Topical 4% Hydroquinone Cream Compared to Topical 4% Hydroquinone Cream Alone in Patients with Melasma: A Split-Face Study

Abstract

Introduction Melasma is an acquired pigmentary disorder characterized by hyperpigmented macules and/or patches affecting sun-exposed skin. Tranexamic acid (TA) can reduce melanin content of epidermis. Thus, we conducted this study to evaluate the efficacy and safety of tranexamic acid local infiltration in combination with topical 4% hydroquinone cream compared to topical 4% hydroquinone cream alone in patients with melasma. Material and Methods This study was a prospective assessor- and analyst-blind, randomized split-face clinical trial which was performed on patients with bilateral malar epidermal melasma. A total of 55 patients were enrolled, and each side of their face was randomly allocated to either TA+HQ or HQ alone treatment. The MASI score was applied as an objective measurement to compare two treatment groups. The patient's satisfaction of melasma treatment was evaluated using a four-scale grading, as well. Results The mean of MASI score in week 16 decreased in both groups significantly (p < 0.01). The therapeutic outcomes were significantly better in TA+HQ group than HQ group (p=0.001). Patients satisfaction with treatment was significantly higher in the TA + HQ group. The difference between the two groups regarding side effect occurrence was not statistically significant. Conclusion Addition of tranexamic acid injections to conventional hydroquinone therapy can increase the efficacy of topical treatment. This trial is registered with IRCT2015110324865N1.

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“…In a study, the authors investigated the signs of toxicity after exposure of o/w formulation comprising 5% hydroquinone (HQ) and a different base. The major challenge associated with HQ is its poor permeability and physicochemical stability, which leads to the use of p-benzoquinone (pBQ) in the formulation which is known as carcinogenic [127][128][129].…”

Development of a Direct Method of Analyzing Tranexamic Acid Levels in Whitening Cream Using Reversed Phase High-Performance Liquid Chromatography

“…The results of each trial were recorded and used to calculate the coefficient of variation (CV). The required CV was ≤2% [5].…”

“…Some studies additionally stated that TA has greater efficacy with fewer side effects. TA has emerged as a promising treatment for melasma both alone and in combination with other treatments [4][5][6]. TA is used as a whitening and moisturizing agent in cosmetic formulations at a concentration of 2.5% [7].…”

The emerging importance of tranexamic acid in dermatology

“…Synergistic therapeutic effects upon melasma have been reported when combining topical TA with Q‐switched neodynium:yttrium–aluminium–garnet (Nd:YAG) laser and intradermal TA with 4% hydroquinone cream . Application of a topical serum containing TA 3%, kojic acid 1% and nicotinamide 5% resulted in significant objective improvement in melasma, hyperpigmentation and postinflammatory hyperpigmentation (PIH) after 12 weeks…”