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临床试验/NCT02546076
NCT02546076撤回2 期

Within-subject Randomized Clinical Trial Comparing Dual-mode ER:YAG Laser in Patients With Long Keloid/Hypertrophic Scars

Insel Gruppe AG, University Hospital Bern0 个研究点开始时间: 2016年5月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
撤回
主要终点
Any reduction from baseline of scars volume as assessed by image analysis

研究概览

简要总结

Skin injuries due to trauma are relatively common, and patients are very concerned about scars caused by trauma and primary repair. Recently, the use of ablative and non-ablative lasers based on the fractional approach has become a novel strategy for the treatment of scars.

The objective of this study is to compare the efficacy of dual-mode Er:YAG laser delivering pulses either with and without heat/coagulation in a cohort of patients with long keloid/hypertrophic scars.

The main hypothesis is that ablative fractional laser without heat/coagulation is equivalent to laser with heat/coagulation in terms of scars volume reduction, while the secondary hypothesis is that ablative fractional laser without heat/coagulation is superior in terms of post-operative erythema and hypopigmentation reduction.

详细描述

Background

Skin injuries, such as lacerations or abrasions, due to trauma are relatively common, and patients are very concerned about scars caused by trauma and primary repair. Multiple modalities for improving the clinical appearance of scars have been attempted with varying success, including corticosteroids, dermabrasion, surgical revision, chemical peeling, silicone gel application, pressure therapy, and radiation. Lasers such as the carbon dioxide (CO2), erbium: yttrium-aluminum-garnet (Er:YAG), and pulsed dye (PDL) lasers have all been used with differing success in the treatment of scars. The goal of all these treatments is to soften depressions and stimulate neocollagenesis in order to fill in the residual defects.

Ablative lasers used for skin resurfacing, such as the CO2 and Er:YAG laser, can reduce various scars, but significant adverse effects limit their use, and patient downtime can be extensive. Owing to these potential risks, nonablative lasers have been developed as a safe alternative to ablative laser resurfacing, and have been reported to be effective and safe for scars. However outcomes have remained unsatisfactory and require several treatments to achieve satisfactory efficacy.

Recently, the use of ablative and non-ablative lasers based on the fractional approach has become a novel strategy for the treatment of scars, and some authors have suggested that treatment with fractional lasers for various scars, such as postoperative, atrophic, and acne scars, has been demonstrated to safely improve the appearance of the scars. However, there is a lack of studies comparing coagulation modality of such lasers.

Objective

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, Outcomes Assessor)

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

  • •Given written informed consent
  • •Skin type I-IV
  • •Presence of long keloid/hypertrophic scar of at least 3 cm² and of uniform/symmetric type
  • •Willingness and ability to adhere study protocol

排除标准

  • •History of adverse events related to ablative fractional laser therapy
  • •Ablative resurfacing within the last 6 months on the scar
  • •Oral retinoid, any immunosuppressive treatments in the last 6 months
  • •Pregnancy, lactation

研究组 & 干预措施

Laser coagulation

Active Comparator

Er:YAG laser treatment with coagulation modality

干预措施: Laser coagulation (Device)

Laser w/o coagulation

Active Comparator

Er:YAG laser treatment without coagulation modality

干预措施: Laser w/o coagulation (Device)

结局指标

主要结局

Any reduction from baseline of scars volume as assessed by image analysis

时间窗: 24 weeks

次要结局

  • Any improvement of scars as assessed by physician according to an ordinal 6-points scale(4, 8, 12, 16, 24 weeks)
  • Overall patient satisfaction to the proposed therapy as assessed by visual analogue scale(16, 24 weeks)
  • Erythema index as assessed by image analysis(4, 8, 12, 16, 24 weeks)
  • Hypopigmentation as assessed by image analysis(4, 8, 12, 16, 24 weeks)
  • Any reduction from baseline of scars volume as assessed by image analysis(4, 8, 12, 16, 24 weeks)

研究者

申办方类型
Other
责任方
Sponsor

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