跳至主要内容
临床试验/NCT07195539
NCT07195539Enrolling By Invitation不适用

CO2 Fractional Laser With Tranexamic Acid As An Effective Tool For Post Burn Hyperpigmentation.

King Edward Medical University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
30
试验地点
1
主要终点
improvement in hyperpigmentation

研究概览

简要总结

It will be a case within control trial. After IRB approval patients presenting with more than 6 months old hyperpigmented burn scars will be included in this study.

All data (including age, gender, mode of burn) will be recorded on a proforma and standardized pre-intervention photographs will be taken. The hyperpigmented scar will be divided into two equal halves.One half will receive fractional CO2 wit TXA solution other half will receive fractional CO2 Laser with N/S solution.Thus allocation will be done randomly with the lottery method.

Total 3 sessions of LADD will be done with 1 month interval between each session. The following settings will be used: probe frequency 75Hz; Power range 12-15W; dwell time 300 micros-500 micros, stach 1-2 and spacing 900-1200m. The TXN solution will be prepared by mixing 250mg of TXA in 5ml of N/S creating a 5% TXN solution. Standardized photographs will again be taken 3 months after the 3rd session. The pre- and post-treatment photographs will be assessed by Skin Hyperpigmentation Index (SHI) using a smartphone dermatoscope adapter and an online calculator, freely available at: https://shi.skini magea nalys is.com, can be used. 15. Any complications during treatment will be noted and documented. Patient satisfaction wil be measured on a Likert scale of 1-5.

详细描述

TITLE:

CO2 FRACTIONAL LASER WITH TRANEXAMIC ACID AS AN EFFECTIVE TOOL FOR POST BURN HYPERPIGMENTATION.

INTRODUCTION Hyperpigmentation is one of the most common sequelae of burns and is due to dysregulation of normal wound healing after burn injury to skin1,2. The proinflammatory cytokine response after a burn stimulates melanocyte proliferation causing increased melanogenesis3. Patients with darker skin are more likely to have hyperpigmented scars. These cosmetically unappealing scars are even more concerning when they involve visible areas of the body, such as the face and hands.

Nonsurgical interventions to prevent or reduce hyperpigmentation of burn scars includes UV protection, hydroquinone application, silicone gel/sheet, nanofat grafting, cryotherapy, and laser and light therapy4. It has also been demonstrated that the earlier the intervention, the better the outcomes are likely to be.

Laser therapy has emerged as a minimally invasive intervention with short post-operative recovery5. Lasers are broadly categorized as ablative or non-ablative, and fractional or non-fractional. Ablative lasers such as the carbon-dioxide (CO2) and Erbium: Yag lasers are generally more effective, but pose a risk of adverse events such as infection, scarring and worsening of pigmentation6. Fractional photo-thermolysis, first described in 2004, leaves columns of non-treated areas between treated columns, thus allowing better wound healing7. Therefore, fractional lasers balance the efficacy of ablative lasers and the safety of non-ablative lasers. Fractional CO2 laser serves to increase dermal pliability, improve abnormal texture, reduce thickness and rehabilitate mature old scars8. A meta-analysis by Zhang et al demonstrated that fractional CO2 laser improved the appearance and pigmentation of post burn scars9.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

  • •Managed conservatively and healed within 3-4 weeks
  • •Age more than 18y
  • •Hyperpigmented Burn scar presenting after 6 months
  • •Patients with burn scar on face, neck, hands

排除标准

  • •Pregnant and breast feeding women
  • •Previous laser treatment
  • •Coagulation or platelet disorder
  • •Patients on anticoagulant medications/birth control pills
  • •DM/Connective tissue disorder
  • •Active viral infection
  • •History of malignancy/chemotherapy.

研究组 & 干预措施

hyperpigmented lesion divided into halves and one for tranexamic acid one for saline

Experimental

this will be a split face study, each lesion will be divided into 2 halves one half will receive tranexamic acid spray while other will receive saline spray. each patient will act as his own control.

干预措施: Tranexamic Acid sprinkle with CO2 LASER (Other)

结局指标

主要结局

improvement in hyperpigmentation

时间窗: 3 months after completion of sessions

hyperpigmentation

时间窗: 3months after completion of sessions

Skin Hyperpigmentation Index will be used to determine improvement in hyperpigmentation.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shumaila Dogar

Senior Registrar

King Edward Medical University

研究点 (1)

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