Comparative Efficacy of Azelaic Acid 20% Cream Versus Hydroquinone 4% Cream as an Adjuvant to Oral Tranexamic Acid in Melasma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Melasma Area and Severity Index
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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)
干预措施: Group A 4 % Hydroquinone Cream Topically and Oral Tranexamic Acid (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.
干预措施: Group B Azelaic Acid 20 % Cream for 6 months (Drug)
结局指标
主要结局
Melasma Area and Severity Index
时间窗: 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.
次要结局
未报告次要终点
研究者
Zahra Nigar
Principal Investigator
Combined Military Hospital Abbottabad