Comparison of Azelaic Acid 20 % Cream Versus Hydroquinone 4% Cream as an Adjuvant to Oral Tranexamic Acid in Melasma
Status:
Completed
Trial end date:
2023-04-30
Target enrollment:
Participant gender:
Summary
Methodology: Fifty female patients presented with melasma (symmetrically distributed
hyperpigmented macules and patches on the face) diagnosed by consultant dermatologist on
clinical presentation were included in this study. The sample size was calculated by WHO
Sample Size calculator taking 31% proportion of excellent response with 4% hydroquinone as an
adjuvant to oral tranexamic acid as compared to 2.25% proportion of excellent response with
20% azelaic acid, 80% power of test and 5% significance level. After randomization, patients
were divided into two groups. Group A was managed with 4% hydroquinone cream as an adjuvant
to oral tranexamic acid (250 mg twice daily) while group B was managed with topical 20%
azelaic acid (daily at night) for six months. Clinical evaluation was done initially at the
start of therapy and then at 2nd, 4th and 6th month using MASI score and patient's response.
Efficacy was assessed in both groups at the end of therapy after six months.