Tranexamic Acid Versus Fractional CO2 Laser in Post-inflammatory Hyperpigmentation in Acne Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 25
- 主要终点
- Measurement of melanin index to assess change of post-acne hyperpigmentation
研究概览
简要总结
comparing between the effect of intradermal injection of TXA and low power low density fractional CO2 lasers on post acne hyperpigmentation
详细描述
Randomized controlled split-face study. One side of the face will be assigned to TXA intradermal microinjection using Kapron 500mg/5ml ampoules (Amoun Pharmaceutical Company), the dose of 1 ml syringe with 100mg/ml. TXA will be prepared under sterile conditions. Injections will be applied intradermally on hyperpigmented areas at 1cm intervals. The injection will be repeated every two weeks for three months. The other side of the face will be randomly assigned to low power fractional CO2 laser with a power of 12 watts, spacing 700 micrometers (low density), and dwell time 300 microsecond every four weeks for three 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
- Double (Participant, Investigator)
盲法说明
Method of randomization: using closed envelopes containing cards with fractional CO2 Rt and fractional CO2 Lt and the patient will draw one of them blindly.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Egyptians of both sexes.
- •Patients who can avoid sun exposure one week after sessions.
- •Patients who stopped taking systemic isotretinoin for more than six months.
排除标准
- •Pregnancy and lactation.
- •Concomitant use of anticoagulants.
- •Bleeding disorders.
- •Personal or family history of DVT or thromboembolic events.
- •Scarring and keloid tendency.
- •Active skin infection, active HSV.
- •History of photosensitivity or photosensitizing medication.
- •Occupational sun exposure.
研究组 & 干预措施
Tranexamic acid injection (Kapron)
One side of the face will be assigned to TXA intradermal microinjection using Kapron 500mg/5ml ampoules (Amoun Pharmaceutical Company), the dose of 1 ml syringe with 100mg/ml. TXA will be prepared under sterile conditions. Injections will be applied intradermally on hyperpigmented areas at 1cm intervals. The injection will be repeated every two weeks for three months.
干预措施: Tranexamic Acid (Drug)
Fractional CO2 laser resurfacing
The other side of the face will be randomly assigned to do low power fractional CO2 laser with a power of 12 watts, spacing 700 micrometers (low density), and dwell time 300 microsecond every four weeks for three months.
干预措施: Fractional CO2 laser (Device)
结局指标
主要结局
Measurement of melanin index to assess change of post-acne hyperpigmentation
时间窗: 3 months
the melanin index (MI) average is 1.10 +/-0.29 with higher values showing worse outcome. It will be measured using reflectance spectrophotometer in order to assess the degree of hyperpigmentation
Measurement of erythema index to assess change of post-acne hyperpigmentation
时间窗: 3 months
the erythema index (EI) average is 1.29 +/- 0.38 with higher values showing worse outcome. It will be measured using reflectance spectrophotometer in order to assess the degree of erythema
Measurement of post-acne hyperpigmentation index to assess change of post-acne hyperpigmentation
时间窗: 3 months
the post-acne hyperpigmentation index (PAHPI) ranges from 6-22 with higher values showing worse outcome. It is a summation of three scores (Postinflammatory hyperpigmentation(PIH) lesion size, median lesion intensity compared with surrounding skin and the number of PIH lesions).
Patient satisfaction score to assess change of post-acne hyperpigmentation
时间窗: 3 months
It is a score ranging from 1-4 with improvement 0-25%=1, 26-50%= 2, 51-75%=3 and more than 75%=4 so higher values of patient satisfaction score showing better outcome
次要结局
未报告次要终点
研究者
Maha Fathy Elmasry
principal investigator
Cairo University