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Completed

NCT Number: NCT05887219

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

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.

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Key information

Conditions

Melasma Hyperpigmentation Melanosis Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Zahra Nigar

Abbottabad, KPK, 22010, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group A 4 % Hydroquinone Cream Topically and Oral Tranexamic Acid

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

Drug

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

Primary outcomes

  1. Melasma Area and Severity Index

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Combined Military Hospital Abbottabad

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 2, 2023
Registry last updated
Jun 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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