Title: Safety and Efficacy Profile of Oral Tranexamic Acid v/s Tranexamic Acid Soaks v/s Tranexamic Acid Cream in Treatment of Melasma – A Hospital Based Prospective Randomised Controlled Comparative Study

Authors: Shraddha J. Patil, Varsha Jamale, Mohan Kale, Balkrishna Nikam, Asma Hussain, Natasha Vijayendran

 DOI:  https://dx.doi.org/10.18535/jmscr/v6i2.23

Abstract

Background: Melasma is an acquired hypermelanosis; treatment of which is challenging. Tranexamic acid is new modality for melasma. This is the first clinical study comparing single drug tranexamic acid in three different forms i.e. oral, soaks and cream in treatment of melasma.

Aim: The present study was conducted to evaluate the safety and efficacy profile of oral tranexamic acid v/s tranexamic acid soaks v/s tranexamic acid cream in the treatment of melasma.

Materials And Methods: 90 patients of melasma were enrolled in the study. They were divided into three groups. 30 patients were treated with oral tranexamic acid (250 mg twice daily), 30 with tranexanic acid solution (5ml) soaks and 30 with tranexamic acid cream twice daily. Efficacy parameters used were Melasma Area Severity Index (MASI), Physician Global Assessment (PGA) and Visual Analogue Scale (VAS). Efficacy was evaluated fortnightly for a period of twelve weeks.

Results: At the end of the study there was 95.8%, 47.6% and 19.6% reduction in MASI score in the oral, compresses and cream groups respectively. The response to oral tranexamic acid was more efficacious compared to tranexamic acid soaks which showed fairer results and then tranexamic acid cream. The difference was statistically significant (p<0.05). The side effects were minimal and did not necessitate withdrawal of treatment.

Conclusion: Oral tranexamic acid, tranexamic acid soaks and tranexamic acid cream are efficacious in the treatment of melasma. However, oral tranexamic acid is more efficacious followed by soaks and then the cream which is least effective.

Keyword: Melasma, Tranexamic acid.

References

  1. Jimbow, K. and Minamitsuji, Y. (2001), Topical therapies for melasma and disorders of hyperpigmentation. Dermatologic Therapy, 14: 35–45.
  2. Agostoni A, Marasini B, Cicardi M, Martignoni G, Uziel L, et al. (1978) Hepatic function and fibrinolysis in patients with hereditary angioedema undergoing long-term treatment with tranexamic acid. Allergy 33: 216-221.
  3. Wang N, Zhang L, Miles L, Hoover-Plow J. Plasminogen regulates pro-opiomelanocortin processing. J Thromb Haemost. 2004;2:785–96.
  4. Chang WC, Shi GY, Chow YH, Chang LC, Hau JS, Lin MT, et al. Human plasmin induces a receptor-mediated arachidonate release coupled with G proteins in endothelial cells. Am J Physiol. 1993;264:C271–81.
  5. Ando H, Matsui MS, Ichihashi M. Quasi-drugs developed in Japan for the prevention or treatment of hyper pigmentary disorders. Int J Mol Sci. 2010;11:2699–700.
  6. Poojary S, Minni K (2015) Tranexamic Acid in Melasma: A Review. Pigmentary Disorders 2: 228 doi:10.4172/2376-0427.1000228
  7. Jae Kyung Kim, Sung Eun Chang, Chong Hyun Won, Mi Woo Lee, Jee Ho Choi, Kee Chan Moon. Dramatic Improvement of Long Standing Post-Inflammatory Hyperpigmentation By Oral and Topical Tranexamic acid. Journal of Cosmetics, Dermatological Sciences and Vpplications, 2012, 2, 62-63
  8. Neema S, Chatterjee M. Dermoscopic Characteristics of Melasma in Indians: A Cross-sectional Study.Int J Dermoscop 2017;1(1):6-10.
  9. Maeda K, Naganuma M. Topical trans-4-aminomethyl cyclohexanecarboxylic acid prevents ultraviolet radiation-induced pigmentation. J Photochem Photobiol B. 1998;47:136–41.
  10. Kanechorn Na Ayuthaya P, Niumphradit N, Manosroi A, Nakakes A (2012) Topical 5% tranexamic acid for the treatment of melasma in Asians: a double-blind randomized controlled clinical trial. J Cosmet Laser Ther 14: 150-154.
  11. Pichardo R, Vallejos Q, Feldman SR, Schulz MR, Verma A, Quandt SA, et al. The prevalence of melasma and its association with quality of life in adult male Latino migrant workers. Int J Dermatol. 2009;48:22-6.
  12. Sufan Wu, Hangyan Shi, Hua Wu, Sheng Yan, Jincai Guo, Yi Sun, Lei Pan. Treatment of melasma with oral admini-stration of tranexamic acid Aesthetic Plastic Surgery 2012;36(4):  964-70
  13. Aamir S, Naseem R. Oral tranexamic acid in treatment of melasma in Pakistani population: a pilot study. Journal of Pakistan Association of Dermatologists 2014;24 (3):198-203
  14. Kim K, Chang SE, Won CH, Lee M W, et al. "Dramatic Improvement of Long Lasting Post-Inflammatory Hyper pigmentation by Oral and Topical Tranexamic Acid," Journal of Cosmetics, Dermatological Sciences and Applications, Vol. 2 No. 2, 2012, pp. 62-63.
  15. Kim MS, Chang SE, Haw S, Bak H, Kim YJ, Lee MW (2013), Tranexamic acid solution soaking is an excellent approach for rosacea patients: A preliminary observation in six patients. The Journal of Dermatology 2012;40: 70–71
  16. Banihashemi, M, Zabolinejad, N, Jaafari, MR, Salehi M, Jabari A. Comparison of therapeutic effects of liposomal Tranexamic Acid and conventional Hydroquinone on melasma. Journal of Cosmetic Dermatology 2015;14:174–177
  17. Atefi N, Dalvand B,  Ghassemi M, Mehran G,  Heydarian A. Therapeutic Effects of Topical Tranexamic Acid in Comparison with Hydroquinone in Treatment of Women with Melasma. Dermatology and Therapy . 2017;(3):417–424
  18. Lee HC, Thng TG, Goh CL (2016). Oral tranexamic acid in the treatment of melasma: A retrospective analysis. Journal of The American Academy of Dermatology, 75, 385–392.
  19. Tse TW, Hui E (2013) Tranexamic acid: an important adjuvant in the treatment of melasma. J Cosmet Dermatol 12: 57-66.

Corresponding Author

Shraddha J. Patil

Department of Dermatology, Krishna Institute of Medical Sciences,

Karad, Maharashtra, India-415110

Email: This email address is being protected from spambots. You need JavaScript enabled to view it., Phone No- 8412914684