Efficacy and Safety of Oral Tranexamic Acid as an Adjuvant in Indian Patients With Melasma Journal of the European Academy of Dermatology and Venereology: JEADV
TAKE-HOME MESSAGE
- In this blinded, controlled clinical trial, 120 Indian patients with facial melasma were given either oral tranexamic acid 250 mg and oral ranitidine 150 mg twice daily (n = 61) or placebo tablets (n = 59) for 12 weeks. Both groups also used a triple-combination cream of fluocinolone 0.01%, tretinoin 0.05%, and hydroquinone 2% daily. After 12 weeks, marked improvement in melasma was seen in the intervention group (65.6% vs 27.1%; P = .0001), which was maintained to the 24th week despite stopping all treatment (65.6% vs 11.9%; P = .0001). Gastrointestinal complaints and hypomenorrhea were more common in the intervention group.
- This study suggests that oral tranexamic acid is an effective adjuvant to topical therapy in the treatment of melasma in Indian patients. In this study, the benefit of oral tranexamic acid was also sustained over a treatment-free follow-up period of 12 weeks.
– Margaret Hammond, MD
- Written by
This paper contains great news for the dermatologist who treats melasma. The authors answer many of the questions concerning the safety and efficacy of using TXA, alongside a physical sunblock and a "Kligman-type" cream. Most importantly, it places TXA at the core of treating melasma. This well-designed and controlled study convincingly redirects our treatment at the causal dysfunction of the disease, and statistically proves that TXA is much more effective than just using topical creams. Adding 12 weeks of TXA is not only safe and tolerable, but also it significantly clears dyschromia and produces a sustained benefit for at least 12 weeks more after stopping TXA and creams. My clinical experience confirms these results (I also include monthly 20%-30% salicylic acid peels).
With 130 participants randomized in two blinded groups, the authors found that the group treated with oral TXA and a triple combination cream had significantly better results than the group treated with placebo tablets and triple combination cream at the end of 12 weeks of treatment. An additional 12 weeks after treatment ended, there was still a notable difference between the two groups, with sustained improvement in the group treated with oral TXA.
Thromboembolism can be a major concern for patients taking TXA and should be taken into consideration before prescribing this treatment; however, no serious side effects of any kind were seen during the course of this study. The most common side effects are gastrointestinal and can be resolved by discontinuing treatment or using antacids.
Overall, these results offer a valuable new treatment for patients with melasma and should be considered as a primary treatment option. Finally, we have a real hope in helping our patients with melasma.
Abstract
BACKGROUND
Melasma is a chronic recalcitrant pigmentary disorder whose treatment frustrates physician and patient alike. Tranexamic acid, a plasmin inhibitor, has demonstrated hypopigmenting properties.
AIM
To compare safety and efficacy of combination of oral tranexamic acid (TXA) and topical fluocinolone-based combination cream (FbTC) with that of topical FbTC alone in melasma.
METHOD
One hundred and eighty patients patients of facial melasma of either sex attending dermatology OPD were screened. Consenting 130 participants were randomized into two blinded groups with 65 patients in each group. Group A patients received oral tranexamic acid 250 mg and oral ranitidine 150 mg twice daily and applied a triple combination cream containing fluocinolone acetonide 0.01%, tretinoin 0.05% and hydroquinone 2% once daily, and Group B was asked to take placebo tablets (calcium lactate and multivitamin) and apply the cream only for 12 weeks. Response was evaluated using modified melasma area severity index (mMASI) and graded mMASI improvement at 4th, 8th and 12th weeks, and at 24th week for recurrence. Data were analysed using SPSS software.
RESULTS
Results were analysed in 120 patients who completed the study with 61 and 59 patients in group A and B, respectively. Demographic profile was equally distributed in both the groups. In group A, 13.1% patients showed marked improvement (>75%) in mMASI as compared to group B (1.7%) at 4th week. By 12th week, 65.6% patients had marked improvement in group A in contrast to only 27.1% in group B. At 24th week, group A (65.6%) had sustained improvement as compared to group B (11.9%) despite stopping treatment; all of which were statistically significant. Recurrence observed was 18.03% in group A vs. 64.4% in group B at 24th week.
CONCLUSION
Oral tranexamic acid is definitely a boon to the armamentarium of melasma management and should be used as an adjuvant to fluocinolone-based triple combination cream for a faster, sustained improvement and to prevent recurrence.
Efficacy and Safety of Oral Tranexamic Acid as an Adjuvant in Indian Patients With Melasma: A Prospective, Interventional, Single-Centre, Triple-Blind, Randomized, Placebo-Control, Parallel Group Study
J Eur Acad Dermatol Venereol 2020 Jun 22;[EPub Ahead of Print], K Minni, S PoojaryFrom MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.
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posted by dermatica at
December 11, 2020
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