Efficacy of tranexamic acid microneedling versus intradermal injection of tranexamic acid in the treatment of Melasma-A Randomized controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Modified Melasma Area and Severity Index (Modified MASI) score: Primary outcome to assess treatment response.
研究概览
简要总结
Melasma is a complicated disorder whose management is very resistant to treatment and also affects the quality of life adversely.Incidence among Indians are 10%.1st line treatment includes topical medications followed by chemical peels and lasers.Despite numerous therapies treatment remains difficult.So there is a need for study of novel agents like Tranexamic acid in the treatment of Melasma.So this study attempts to compare the efficacy of Tranexamic acid micro needling and Intradermal injection in the treatment of Melasma among the Outpatients of the department of dermatology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients with Epidermal/Dermal /Mixed type of melasma 2.Patients willing for consent, study and follow up.
排除标准
- •1.Pregnancy 2,Patients on hormone replacement therapy 3.Patients on contraceptive pills 4.Patients on anticoagulants 5.Allergic to drugs under the study 6.Non compliant patients 7.Patients with keloidal or Hypertrophic scar tendency 8.Patients with the history of depigmenting treatment in the past 1 month 9.Moderate to severe acne vulgaris on face 10.History of Herpes infections, Warts.
结局指标
主要结局
Modified Melasma Area and Severity Index (Modified MASI) score: Primary outcome to assess treatment response.
时间窗: At baseline,4weeks, 8weeks & 12 weeks and followed up for further 2 months at monthly intervals.
次要结局
- Patient global assessment scale and(At baseline, 4weeks, 8weeks & 12 weeks and followed up for further 2 months at monthly intervals.)
- Clinical improvement assessed based on photographic document(At baseline, 4weeks, 8weeks & 12 weeks and followed up for further 2 months at monthly intervals.)