Comparing Tranexamic Acid Microinjection Alone Versus Its Combination With Fractional Carbon Dioxide Laser in Melasma Treatment
试验速览
- 阶段
- 4 期
- 入组人数
- 25
- 主要终点
- Melanin and Erythema indices change from baseline
研究概览
简要总结
The objective of this study is to assess and compare the efficacy of tranexamic acid intradermal microinjection alone versus its combination with low power fractional CO2 laser in a sequential pattern.
In all participants one half of the face will be randomly assigned to low power fractional CO2 laser while other side to Tranexamic acid intradermal microinjections on the 1st session. This split face session will be repeated every six weeks for 3 sessions.
In addition, Tranexamic acid intradermal microinjections will be applied for full face at the 2nd and 4th week of each split face session.
The response will be evaluated by the Melanin and erythema Indices which will be measured using reflectance spectrophotometer, Dermoscopy and photography before starting the study, two and four weeks after the last session. The sessions will take 4 months for each patient and another one month free of sessions for follow up.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with bilateral symmetrical facial melasma
排除标准
- •Pregnancy and lactation.
- •Patients taking oral contraceptive pills or hormonal replacement therapy at the time of the study or during the past 12 months.
- •Concomitant use of anticoagulants.
- •Bleeding disorders.
- •Personal or family history of deep venous thrombosis or thromboembolic events.
- •Scarring and keloid tendency.
- •Active skin infection, active Herpes simplex virus.
- •History of Post-inflammatory hyperpigmentation.
- •History of photosensitivity or photosensitizing medication as sulfonamides tetracycline,retinoids, bleaching creams, peeling and laser two months before the study.
- •Occupational sun exposure.
研究组 & 干预措施
Fractional CO2 laser combined with Tranexamic acid
one side of the face of all participants will be subjected to low power fractional CO2 laser with a power of 12 watts, spacing 800 micrometer (7.3% density), and dwell time 300 microsecond for 3 sessions every 6 weeks. In addition to Tranexamic acid intradermal microinjections using tranexamic acid 500mg/5ml ampoules, the dose of 1ml syringe with 100mg/ml with maximum of 4ml per session, on the 2nd and the 4th week of each laser session. With total treatment time for each patient of 4 months and another month free of sessions for followup.
干预措施: Fractional CO2 laser (Device)
Fractional CO2 laser combined with Tranexamic acid
one side of the face of all participants will be subjected to low power fractional CO2 laser with a power of 12 watts, spacing 800 micrometer (7.3% density), and dwell time 300 microsecond for 3 sessions every 6 weeks. In addition to Tranexamic acid intradermal microinjections using tranexamic acid 500mg/5ml ampoules, the dose of 1ml syringe with 100mg/ml with maximum of 4ml per session, on the 2nd and the 4th week of each laser session. With total treatment time for each patient of 4 months and another month free of sessions for followup.
干预措施: Tranexamic acid intradermal microinjections (Drug)
Tranexamic acid alone
the other side of the face of all participants will be subjected Tranexamic acid intradermal microinjections using tranexamic acid 500mg/5ml ampoules, the dose of 1ml syringe with 100mg/ml with maximum of 4ml per session, every 2 weeks for 4 months then another month free of sessions for followup.
干预措施: Tranexamic acid intradermal microinjections (Drug)
结局指标
主要结局
Melanin and Erythema indices change from baseline
时间窗: baseline, 18 weeks and 20 weeks
Comparing the effect of Tranexamic acid intradermal microinjection alone versus its combination with low power fractional CO2 laser in a sequential pattern on melasma improvement by measuring the Melanin and erythema Indices (MI and EI) using reflectance spectrophotometer before starting the study, two and four weeks after the last session.
Dermoscopic features change from baseline
时间窗: baseline, 18 weeks and 20 weeks
Comparing the effect of Tranexamic acid intradermal microinjection alone versus its combination with low power fractional CO2 laser in a sequential pattern on melasma improvement by Dermoscopy before starting the study, two and four weeks after the last session.
次要结局
未报告次要终点
研究者
Eman Raafat Said
Lecturer of Dermatology Department, Faculty of Medicine
Cairo University