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临床试验/NCT04719559
NCT04719559已完成不适用

Combined Use of Fractional Laser and Steroid Ointment to Improve the Old Scar After Thyroidectomy

Chang Gung Memorial Hospital2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2018年3月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
10
试验地点
2
主要终点
Self-assessment by patients after treatment

研究概览

简要总结

This clinical study was conducted to assess the effects of LADD combined with a fractional ablative carbon dioxide laser and a topical steroid for the treatment of post-thyroidectomy hypertrophic scars.

详细描述

Thyroidectomy results in unsightly scarring at the anterior neck of the patient. A clinical study was conducted to assess the effectiveness of five courses, applied every 4 weeks, of laser-assisted drug delivery (LADD) combining a fractional ablative carbon dioxide laser and topical 0.05% clobetasol propionate to the treatment of post-thyroidectomy hypertrophic scars in patients. Assessments of the scars by the patient themselves according to the patient and observer scar assessment scale.

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
20 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients had presented a persistent hypertrophic scar at the neck region for more than 1 year after their thyroidectomy.

排除标准

  • Systemic chronic disease or a history of autoimmune disease or human immunodeficiency virus infections.

结局指标

主要结局

Self-assessment by patients after treatment

时间窗: 1 year after the first treatment

For each patient's self-assessment1 year after the first treatment, we adopted the patient and observer scar assessment scale (POSAS)18, with a range of 1-10 for representing the severity of the itchiness, pain, color, softness, thickness, irregularity, and distorted appearance of the scar.

Self-assessment by patients before treatment

时间窗: before first treatment

For each patient's self-assessment before the first treatment, we adopted the patient and observer scar assessment scale (POSAS)18, with a range of 1-10 for representing the severity of the itchiness, pain, color, softness, thickness, irregularity, and distorted appearance of the scar.

Doctor evaluations using the POSAS scoring range of 1-10

时间窗: 1 year after the first treatment

Four doctors participated as observers of the clinical outcomes. One of the doctors carried out all treatments and evaluated seven parameters, namely, vascularity, pigmentation, thickness, relief, pliability, surface area, and overall opinion based on the POSAS using a scoring range of 1-10, from normal to worst conditions 1 year after the first treatment. The remaining three doctors acted as observers to evaluate the general appearances of the scars based on photographs captured by the same photographer with the same camera 1 year after the first treatment. They then rated the scar on a score of 1-10.

次要结局

未报告次要终点

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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