Comparative Study for the Treatment of Freckles by Intradermal Tranexamic Acid Versus Q Switched KTP Laser (532nm)
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pigmentation and severity index by clinical evaluation
研究概览
简要总结
Comparative split face study in which 30 patients with freckles are recruited.One side of the face will be treated with Q Switched (QS)KTP 532nm, and the other side will be treated with intradermal tranexamic acid (TXA).
详细描述
One side of the face will receive QS KTPlaser at a wavelength of 532 nm, spot size 2-3 mm , power 1-1.5J/cm2 and the clinical end point is just frosting.Sessions will be every month for 2 months.
The other side of the face will be assigned to TXA intradermal microinjection in the same session using Kapron 500mg/5ml ampoules (Amoun Pharmaceutical Company), the dose of 1 ml syringe with 100mg/ml. TXA will prepared under sterile conditions. Injections will be applied intradermally on freckles area at.
The sessions of TXA will be every 2 weeks for 2 months.
Postoperatively, topical antibiotic ointment and steriod will be applied. Sunscreen then applied until the next treatment in order to minimize reactive hyperpigmentations.
Follow up after treatment monthly for 2 month.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Both genders
- •Age group > 18years old.
排除标准
- •Pregnant and lactating females.
- •Keloid and scarring tendancy
- •Usage of invasive or semi invasive procedures for treatment of freckles such as chemical peeling , dermaroller..etc. 2 months prior to the study.
- •Oral Isotretinoin 6 months prior to the study.
- •Active herpetic lesions.
- •Any concurrent active skin disease within the treated area.
- •Photosensitive skin conditions such as systemic lupus erythematous.
- •History of delayed wound healing.
- •Bleeding diathesis.
- •Medical conditions such as autoimmune diseases.
研究组 & 干预措施
Participants with freckles (one side of the face)
one randomized side of the face will be treated by Intradermal Tranexamic acid
干预措施: Tranexamic Acid Injectable Product (Drug)
Participants with freckles (other side of the face)
other side will be treated by Q switched KTP laser
干预措施: Q switched KTP (532nm) (Device)
结局指标
主要结局
Pigmentation and severity index by clinical evaluation
时间窗: 6 months to 1 year
Evaluate efficacy of intradermal tranexamic acid versus Q switched KTP laser in the treatment of freckles before treatment, after treatment and after follow-up
Melanin Index change by spectrophotometer
时间窗: 6 months to 1 year
Evaluate efficacy of intradermal tranexamic acid versus Q switched KTP laser in the treatment of freckles before treatment, after treatment and after follow-up
Blinded observers' evaluation
时间窗: 6 months to 1 year
Evaluate efficacy of intradermal tranexamic acid versus Q switched KTP laser in the treatment of freckles before treatment, after treatment and after follow-up
Patient satisfaction rate
时间窗: 6 months to 1 year
Evaluate efficacy of intradermal tranexamic acid versus Q switched KTP laser in the treatment of freckles before treatment, after treatment and after follow-up
次要结局
未报告次要终点
研究者
Rana F Hilal, MD
Lecturer
Kasr El Aini Hospital