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临床试验/NCT07360483
NCT07360483已完成不适用

Treatment of Hypertrophic Scars Using Fractional CO2 Laser Alone in Comparison With Adding Botulinum Toxin Either Through Intralesional Injection or Assisted Drug Delivery

Cairo University0 个研究点目标入组 48 人开始时间: 2025年1月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
48

研究概览

简要总结

The current study aimed to evaluate the effectiveness of fractional laser treatment alone and fractional laser combined with botulinum toxin A, delivered either through injections or topical application fractional laser-assisted drug delivery (FLADD) in hypertrophic burn scar

详细描述

Burn injuries represent a major global health concern, often resulting in long term physical, psychological, and social consequences. Among the most challenging sequelae are hypertrophic scars, which arise from abnormal wound healing characterized by fibroblast hyperactivity, excessive collagen deposition and impaired extracellular matrix remodeling. These scars not only compromise skin pliability and aesthetics but also restrict mobility, leading to functional disability and reduced quality of life.

Traditional management strategies including surgical excision, corticosteroid injections, silicone gel, pressure therapy, and radiation have shown variable efficacy, with high recurrence rates and limited patient satisfaction. In recent years, minimally invasive modalities such as fractional CO2 laser therapy have gained prominence for their ability to remodel scar tissue and improve texture. Concurrently, botulinum toxin type A (BTXA) has emerged as a promising antifibrotic agent, exerting its effects by reducing wound tension, modulating fibroblast activity, and regulating collagen synthesis.

The integration of fractional CO2 laser with BTXA, delivered either intralesionally or via laser assisted drug delivery, offers a novel therapeutic approach aimed at enhancing scar pliability, contour and patient comfort. This study investigates the comparative efficacy of these modalities in the treatment of post burn hypertrophic scars, providing evidence to guide optimized clinical practice.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Scar Type: Clinically diagnosed hypertrophic burn scar not less than 4.5 cm
  • Minimum Scar Size: 4.5cm x 1 cm
  • Scar duration: At least 1 month old and not exceed 6 months.
  • Fitzpatrick Skin Type: II to IV
  • No Recent Scar Treatment: No scar treatment within the past 6 months
  • Healthy Skin: No active skin infections in the treatment area
  • Normal Neuromuscular Function: No history of neuromuscular disorders or medications affecting muscle function.

排除标准

  • 1) Pregnancy /Lactation: Pregnant, lactating, or planning pregnancy within 6 months 2) patients did previous intervention for the scar for the last 6 months 3) Bleeding Disorders: Known cases of bleeding disorders 4) patients with allergic reaction to botulinum toxin or with neuromuscular junction diseases (eg, myasthenia gravis) 5) patients on medication that decrease neuromuscular transmission (eg, aminoglycosides, penicillamine, quinine, and calcium channel blockers).

研究者

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

Aya Mohamed Fahim

Assistant Professor

Cairo University

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