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

Phase 1

Completed

• Conditions: Melasma
• Interventions: Drug: Group A 4 % Hydroquinone Cream Topically and Oral Tranexamic Acid; Drug: Group B Azelaic Acid 20 % Cream for 6 months

• Registration Number: NCT05887219
• Lead Sponsor: Combined Military Hospital Abbottabad

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-01
• Primary Completion: 2023-04-30
• Study Completion: 2023-04-30
• Status Verified: 2023-05
• Study First Submitted: 2023-05-18
• Study First Submitted QC: 2023-05-31
• Last Update Submitted: 2023-05-31
• Study First Posted: 2023-06-02
• Last Update Posted: 2023-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A 4 % Hydroquinone Cream Topically and Oral Tranexamic Acid	Group A 4 % Hydroquinone Cream Topically and Oral Tranexamic Acid	Group A was managed with 4% hydroquinone cream as an adjuvant to oral tranexamic acid (250 mg twice daily)
Group B Azelaic Acid 20 % cream for 6 months	Group B Azelaic Acid 20 % Cream for 6 months	group B was managed with topical 20% azelaic acid (daily at night) for six months.

Primary Outcome Measures

Name	Time	Method
Melasma Area and Severity Index	6 months	Melasma Area and Severity Index Score was used to assess response to treatment.Lowest score=0,Highest Score 48. High score indicates worse outcome.

Trial Locations

Locations (1)

Zahra Nigar; 🇵🇰 Abbottabad, KPK, Pakistan