Efficacy, Safety and Tolerability of Oral Tranexamic Acid Vs Modified Kligman Formula in Moderate to Severe Melasma

Mithra Rangapriya, D (2017) Efficacy, Safety and Tolerability of Oral Tranexamic Acid Vs Modified Kligman Formula in Moderate to Severe Melasma. Masters thesis, Stanley Medical College, Chennai.


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INTRODUCTION: A commonly acquired disorder which is characterized by symmetric, hyperpigmented patches with a geographic irregular margins, occurring commonly on the sun exposed areas of the face. It is mostly prevalent among middle-aged to young women1. People with darker skin types are more frequently affected. Occurs most commonly among Middle Eastern descent, Asians or Hispanics. AIM AND OBJECTIVES: This study aims to 1. Compare the efficacy, safety and tolerability of oral tranexamic Vs topical Kligman formula in moderate to severe melasma. 2. Compare the end points of the two groups. 3. Identify the common side effects in each group. METHOD AND MATERIALS: OBJECTIVES: To assess the efficacy, safety & tolerability of oral tranexamic acid Vs Modified Kligman formula in moderate to severe melasma. PLACE OF STUDY: Department of Dermatology Govt. Stanley Medical College, Chennai. TYPE OF STUDY: Open Label Prospective, Interventional Study. DURATION: 6 months July 2015-december 2015. SAMPLE SIZE: 20 + 20 = 40. INCLUSION CRITERIA: 1. Female, 2. Age: 18-45, 3. Patients willing for follow up. EXCLUSION CRITERIA: 1. Known hypersensitivity to the drug, 2. Thrombophilic & thromboembolic diseases, 3. Hypercoagulable states, 4. Pt on OCP/HRT, 5. Thyroid dysfunct ion wi th hypothyroid state, 6. H/O cancer in the family, 7. Patients with unexplained fetal loss (antiphospholipid syndrome), 8. ANA positive, 9. Chronic medical illness, 10. Tobacco or alcohol use, 11. Obesity, 12. Pregnancy &lactation, 13. Renal failure, 14. Irregular menstrual cycles, 15. Epileptic, 16. Defective colour vision, 17. Post inflammatory hyperpigmentation & other pigmentary disorders, 18. Medical treatment for melasma within 3 months, 19. Chemical peel or laser treatment within 9 months, 20. Patients on anticoagulants or tretinoin. RESULTS: A total of 40 patients were enrolled in the study who were randomized to either of the two treatment groups. Patient demographics and baseline disease characteristics were generally well balanced across both the treatment groups. The mean age was 35 years and mean MASI score at baseline was 13. The mean duration of melasma was 4 yrs. Total number of patients in the study: 40. This study included 40 female patients. Youngest patient was 27 years of age and oldest was 45 years of age. All the patients fulfilled the inclusion and exclusion criteria. CONCLUSION: Low dose tranexamic acid along with routine sun protective measures provides quick and persistent reduction in pigmentation and the MASI score. Tranexamic acid may be an effective addictive for the management of melasma resistant to routine treatment. Careful screening for personal and familial risk factors of thromboembolism must be carried out before treatment. Following completion of therapy maintenance with regular sun protection are the utmost important measures. All the other treatment modalities aims at either preventing melanin formation by topical depigmenting agents like hydroquinone, azelaic acid, etc or removing pre existing melanin pigments by peeling, lasers. However they may activate melanocytes by inflammation, irritation or injury to keratinocytes resulting in recurrence and post inflammatory hyper pigmentations. Tranexamic acid is the sole agent which prevents the enhancement of the melanocytes via hormones or sunlight and damaged keratinocytes by the prevention of plasminogen activating system. It decreases the occurrence and recurrences of melasma that follows other modalities due to melanocyte activation. As the interact ion between keratinocytes and melanocytes plays an important role in the process of melanogenesis through the PA activation system, it is justified in adding tranexamic acid, the plasminogen activator inhibitor, as an adjunct in the management of melasma, to improve the efficacy of known effective treatments and reduce chance of recurrence. Hence oral TA can be used safely and efficiently in the treatment of melasma. From this study it is observed that oral tranexamic acid was found to be more efficient than kligman formula. It was safe, well tolerated and efficacious.

Item Type: Thesis (Masters)
Additional Information: Reg.No.201430052
Uncontrolled Keywords: Efficacy, Safety, Tolerability, Oral Tranexamic Acid, Modified Kligman Formula, Moderate to Severe Melasma.
Subjects: MEDICAL > Dermatology Venereology and Leprosy
Depositing User: Subramani R
Date Deposited: 22 Jul 2020 16:14
Last Modified: 22 Jul 2020 16:14
URI: http://repository-tnmgrmu.ac.in/id/eprint/12639

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