Meenakshi KHEMKA 医师
医学博士, (Medical student)
An open label one arm clinical trial to assess the efficacy of intralesional tranexamic acid in the treatment of melasma patients from eastern India
Objectives: To assess the efficacy of Intralesional tranexamic acid in melasma treatment using modified Melasma Severity Index (mMASI) score, Physician’s Global Assessment Score (PGA) and Patient’s Global Assessment Score (PtGA).
Introduction: Melasma is common disorder characterised by hyperpigmented patches usually on the face. Various treatment methods have been tried, but none proven fully effective. Tranexamic acid prevents melanin synthesis by interfering with melanocyte keratinocyte interaction by inhibiting the plasmin system. Intralesional tranexamic acid is being studied in the treatment of melasma.
Materials / method: After calculation of sample size 35, proper ethical approval, an Open Label One Arm Clinical Trial was conducted in melasma patients not previously treated with informed consent. Intralesional tranexamic acid injection was administered at 4mg/ml strength locally into the melasma lesions after proper local anaesthesia to minimise discomfort every 2 weekly up to 8 weeks. The mMASI, PGA, PtGA Scores were calculated at baseline,4,8,12 weeks.
Results: Demographic characteristics of the patients include mean age 37.6 years with a male:female ratio 4:31. Baseline mMASI Score at 0 week was 5.91 ± 1.98(mean±SD). After intervention and follow-up at 12 weeks mMASI Score was 3.78 ± 1.39(mean±SD) showing a significant improvement from baseline. Repeated Measures ANOVA after greenhouse-Geisser correction: F=69.6, p= <0.001, η²p=0.672 showed a significant change across timepoints. PGA and PtGA Scores also showed significant improvement over baseline.
Conclusion: The results show Intralesional Tranexamic acid can be a promising, cost effective treatment option for melasma. It is a safer alternative, free from common side-effects that have been noted with conventional topical treatment modalities. A comparative study between Intralesional tranexamic acid and existing gold standard treatment methods (randomised clinical trial) would enhance our understanding in this aspect which our study lacks (one arm clinical trial).
