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

NCT ID: NCT05887219

Last Updated: 2023-06-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2023-04-30

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.

Conditions

Melasma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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 Type: ACTIVE_COMPARATOR

Group A 4 % Hydroquinone Cream Topically and Oral Tranexamic Acid

Intervention Type: DRUG

Group A was managed with 4% hydroquinone cream as an adjuvant to oral tranexamic acid (250 mg twice daily) 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.

Group Type: ACTIVE_COMPARATOR

Group B Azelaic Acid 20 % Cream for 6 months

Intervention Type: DRUG

Group B was managed with topical 20% azelaic acid (daily at night) for six months.

Interventions

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) for 6 months

Intervention Type: DRUG

Group B Azelaic Acid 20 % Cream for 6 months

Group B was managed with topical 20% azelaic acid (daily at night) for six months.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Combined Military Hospital Abbottabad

OTHER

Sponsor Role: lead

Responsible Party

Zahra Nigar

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Zahra Nigar

Abbottabad, KPK, Pakistan

Countries

Pakistan

Other Identifiers

CMHAbbottabad1987

Identifier Type: -

Identifier Source: org_study_id