Comparative Study of Combination of Oral Tranexamic Acid with Modified Kligman’s Formula Versus Oral Tranexamic Acid with Azelaic Acid 15% in the Treatment of Melasma

Abstract

Background: Melasma refers to acquired hyper-pigmentary condition effecting skin. Owing to its multifactorial causation and chronicity, there is an increased need for new multimodality therapies to treat melasma more effectively and to prevent the side effects seen with the conventional modalities of treatment.
 Objectives: Compare efficacy of combining oral Tranexamic Acid and Azelaic Acid 15% with that of Oral Tranexamic Acid (TA) and Modified Kligman’s Formula. Also, to record any adverse effects of combining these agents.
 Methods: Patients having Melasma who will be coming to Dermatology OPD, AVBRH, Sawangi, Wardha, will be enrolled after considering the various inclusion and exclusion criteria. A detailed history will be asked, which will be followed by a cutaneous examination that includes the calculation of MASI (Melasma Area and Severity Index).
 One Group (A) - participants will receive - Oral 500 mg Tranexamic acid OD plus Modified Kligman’s Formula (fluocinolone acetonide 0.01%, tretinoin 0.05%, and hydroquinone 2%) cream one time at night only.
 Second Group (B)- participants will receive - Oral 500 mg Tranexamic Acid OD plus Azelaic Acid 15% gel once daily at night only.
 Both groups will also receive Broad-spectrum sunscreen SPF-30 daily (3 hourly).
 Patients will be called for regular follow up at 4 weeks and 8 weeks (for early results). Clinical photos will be clicked at every follow-up visit and MASI score shall be doocumented.
 Expected Results: To analyze efficacy of combining Oral TA along with Azelaic Acid 15% and if it provides better results, we can avoid the undesirable side effects that are seen on prescribing the Modified Klingman’s Formula, in Melasma patients.
 Conclusion: This study will help us in analyzing efficacy of combining Oral TA with Azelaic Acid 15%, therefore will provide a newer treatment modality with lesser side effects and maybe better results than the gold standard- Modified Klingman’s Formula.

Comparative Study of Combination of Oral Tranexamic Acid With Modified Kligman’s Formula Versus Oral Tranexamic Acid With Azelaic Acid 15% in the Treatment of Melasma

“…Confidentiality and privacy were ensured. The study protocol was reviewed and approved by the Datta Meghe Institute of Medical Sciences (DMIMS) (DU) Institutional Ethics Committee in December 2020 with reference number DMIMS(DU)/IEC/Dec-2020-21/9316 and published in the Journal of Pharmaceutical Research International [ 10 ].…”