Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2015 Sep-Oct;60(5):520.
doi: 10.4103/0019-5154.164416.

Oral Tranexamic Acid with Fluocinolone-Based Triple Combination Cream Versus Fluocinolone-Based Triple Combination Cream Alone in Melasma: An Open Labeled Randomized Comparative Trial

Tanmay Padhi  1 , Swetalina Pradhan  1
Affiliations

Oral Tranexamic Acid with Fluocinolone-Based Triple Combination Cream Versus Fluocinolone-Based Triple Combination Cream Alone in Melasma: An Open Labeled Randomized Comparative Trial

Tanmay Padhi et al. Indian J Dermatol. 2015 Sep-Oct.

Abstract

Background: Melasma is a common acquired cause of facial hyperpigmentation with no definitive therapy. Tranexamic acid, a plasmin inhibitor, has demonstrated depigmenting properties and combining this oral drug with other modalities of treatment has shown promising results.

Objectives: To compare the efficacy of a combination of oral tranexamic acid and fluocinolone-based triple combination cream with that of fluocinolone-based triple combination cream alone in melasma among Indian patients.

Materials and methods: 40 patients of melasma of either sex attending to dermatology OPD were enrolled in this study. Participants were randomly divided into two groups with 20 patients in each group. Group A patients were asked to apply the cream only and Group B patients received oral tranexamic acid 250 mg twice daily and applied a triple combination cream containing fluocinolone acetonide 0.01%, tretinoin 0.05%, and hydroquinone 2% once daily for 8 weeks. Response was evaluated using melasma area severity index (MASI) at baseline, 4 weeks, and 8 weeks.

Results: 40 patients completed the study. The MASI scores at baseline, 4 weeks and 8 weeks in group A were 15.425 + 1.09, 11.075 + 9.167 and 6.995 + 6.056 respectively and in group B 18.243 + 1.05, 6.135 + 4.94 and 2.19 + 3.38. Intergroup comparison showed a faster reduction in pigmentation in Group B as compared to Group A and the results were statistically significant at 4 weeks (P value 0.014) and 8 weeks (P value 0.000). The efficacy was maintained throughout the 6-month follow-up period.

Conclusion: Addition of oral tranexamic acid to fluocinolone-based triple combination cream results in a faster and sustained improvement in the treatment of melasma.

Keywords: Melasma; oral therapy; tranexamic acid; triple combination cream.

PubMed Disclaimer

Conflict of interest statement

Conflict of Interest: Nil.

Figures

Figure 1
Figure 1
Patient flow diagram
Figure 2
Figure 2
Objective assessment of melasma area severity Index (MASI), MASIb score at baseline, MASI 1 score at 4 weeks, MASI 2 score at 8weeks
Figure 3
Figure 3
Pre- and post-treatment photographs in Group A at 0 and 8 weeks
Figure 4
Figure 4
Pre- and post-treatment photographs in Group B at 0 and 8 weeks
See this image and copyright information in PMC

References

    1. Achar A, Rathi SK. Melasma: A clinico-epidemiological study of 312 cases. Indian J Dermatol. 2011;56:380–2. - PMC - PubMed
    1. Sheth VM, Pandya AG. Melasma: A comprehensive update: Part I. J Am Acad Dermatol. 2011;65:689–97. - PubMed
    1. Grimes PE. Melasma: Etiologic and therapeutic considerations. Arch Dermatol. 1995;131:1453–7. - PubMed
    1. Pawaskar MD, Parikh P, Markowski T, McMichael AJ, Feldman SR, Balkrishnan R. Melasma and its impact on health-related quality of life in Hispanic women. J Dermatolog Treat. 2007;18:5–9. - PubMed
    1. Kligman AM, Willis I. A New formula for Depigmenting Human Skin. Arch Dermatol. 1975;111:40–8. - PubMed