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

Melasma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05887219
• Other study ID #: CMHAbbottabad1987
• Status: Completed
• Phase: Phase 1
• Start date: November 1, 2022
• Est. completion date: April 30, 2023

Study information

• Verified date: May 2023
• Source: Combined Military Hospital Abbottabad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Melanosis
• Melasma

Intervention

Drug:
• 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
• Group B Azelaic Acid 20 % Cream for 6 months
Group B was managed with topical 20% azelaic acid (daily at night) for six months.

Locations

Country	Name	City	State
Pakistan	Zahra Nigar	Abbottabad	KPK

Sponsors (1)

Lead Sponsor	Collaborator
Combined Military Hospital Abbottabad

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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