Comparison of Azelaic Acid 20 % Cream Versus Hydroquinone 4% Cream as an Adjuvant to Oral Tranexamic Acid in Melasma

Study Overview
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Brief Summary
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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.

Official Title
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Comparative Efficacy of Azelaic Acid 20% Cream Versus Hydroquinone 4% Cream as an Adjuvant to Oral Tranexamic Acid in Melasma

Conditions
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Melasma

Intervention / Treatment
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* Drug: Group A 4 % Hydroquinone Cream Topically and Oral Tranexamic Acid
* Drug: Group B Azelaic Acid 20 % Cream for 6 months


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A 4 % Hydroquinone Cream Topically and Oral Tranexamic Acid<br>Group A was managed with 4% hydroquinone cream as an adjuvant to oral tranexamic acid (250 mg twice daily) | Drug: Group A 4 % Hydroquinone Cream Topically and Oral Tranexamic Acid<br>* Group A was managed with 4% hydroquinone cream as an adjuvant to oral tranexamic acid (250 mg twice daily) for 6 months<br>|
| Active Comparator: Group B Azelaic Acid 20 % cream for 6 months<br>group B was managed with topical 20% azelaic acid (daily at night) for six months. | Drug: Group B Azelaic Acid 20 % Cream for 6 months<br>* Group B was managed with topical 20% azelaic acid (daily at night) for six months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Melasma Area and Severity Index | Melasma Area and Severity Index Score was used to assess response to treatment.Lowest score=0,Highest Score 48. High score indicates worse outcome. | 6 months |