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临床试验/NCT04461366
NCT04461366已完成不适用

Monopolar Radiofrequency Versus Pulsed Dye Laser for Treatment of Acne Scars: A Randomized Clinical Trial

Cairo University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
acne scars severity by investigator

研究概览

简要总结

Background: The acne scar is a common disorder characterized by skin eruption or abnormalities on face, chest, and/or back in the adolescence which affect the cosmetic appearance.

Purpose: The main aim of this study was to investigate whether monopolar radiofrequency (MRF) or pulsed dye laser (PDL) is more effective in the cases suffering from acne scars in the form of reducing acne scars and improving the cosmetic appearance.

详细描述

Thirty patients suffering from moderate or severe acne scars were randomly assigned into two equal groups. Group A (MRF group): received 2 sessions per week with MRF for 8 weeks. Group B (PDL group): received 1 session per week with PDL for 8 weeks. The severity of acne scars was assessed before and after treatment by using the clinical evaluation scale for acne scarring (ECCA) scale and the self-assessment of clinical acne-related scars (SCARS) scale. Quality of life and the emotional impact of acne scars were evaluated by the facial acne scar quality of life (FASQoL) scale.

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 (Care Provider)

入排标准

年龄范围
19 Years 至 23 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with mild to severe acne scar
  • Patients with acne scar in the face

排除标准

  • Smokers and alcohol drinker
  • Patients who had a history of diabetes, circulatory or sensory disorders
  • Patients who had a history of frequent sunburns
  • Patients with nodulocystic acne

结局指标

主要结局

acne scars severity by investigator

时间窗: after 8 weeks of intervention

Clinical evaluation scale for acne scarring. Using this scale, the type of scar was defined by the qualitative descriptions of scars, which is then accompanied by a numerical score (0-4) and then multiplied by (15-50) which is a weighting factor of clinical severity, the total possible score is from 0 to 540. Higher score means worse outcome while lower score means better out come.

acne scars severity by the participant

时间窗: after 8 weeks of intervention

Self-assessment of clinical acne-related scars questionnaire. It consists of 5-items with 1 hypothesized domain which asks patients to assess acne scars severity as seen in the mirror. The total possible score is from 0- 20. Higher score means worse outcome while lower score means better out come.

次要结局

  • emotional, social functioning and work/school effect of scars(after 8 weeks of intervention)

研究者

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

Nesma Morgan Allam

Lecturer

Cairo University

研究点 (2)

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