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: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Combined Military Hospital Abbottabad
• Treatments: Azelaic acid; Hydroquinone; Tranexamic Acid

Criteria

Inclusion Criteria:

• Female patients

• Aged 20 to 45 years

• Presented with melasma (symmetrically distributed hyperpigmented macules and patches on the face)

• Diagnosed by consultant dermatologist on clinical presentation under wood's light.

Exclusion Criteria:

• Pregnant patients

• Women taking contraceptive pills at the time of study or past 12 months

• Any chronic illness

• Allergy to any of the agents used in the treatment

• Those taking any topical and systemic treatment for melasma in the last one month