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临床试验/NCT06789874
NCT06789874已完成2 期

Comparing the Efficacy of Intralesional Saline Versus 35% Trichloracetic Acid (TCA) Peel in the Treatment of Atrophic Acne Scars

Sheikh Zayed Medical College2 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2023年4月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
126
试验地点
2
主要终点
Observer Scar Assessment Scale

研究概览

简要总结

This study aimed to compare the efficacy of intradermal normal saline versus trichloroacetic acid (TCA) in treating atrophic acne scars. Atrophic acne scars are a common and disfiguring complication, with limited research on the use of normal saline.

详细描述

Acne vulgaris is a common skin problem affecting adolescents and adults. It is the eighth most common skin disease globally, having a prevalence ranging from 35%-85%, with notable variations across different regions and age groups.A randomized controlled trial was conducted at the Dermatology Department, Sheikh Zayed Hospital, Rahim Yar Khan, from 1st April 2023 to 31st October 2023. 126 patients were enrolled. Scar grading was based on Goodman and Baron's Qualitative Scar Classification. The Observer Scar Assessment Scale (OSAS) was used by dermatologists. Patients rated their acne scars using the Visual Disease Severity Scale. Photographs were taken for comparison. Efficacy was defined as ≥50% improvement in the OSAS.

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
None

入排标准

年龄范围
16 Years 至 40 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age: 13-50 years
  • •Clinically diagnosed patients of atrophic acne scars on face
  • •duration of more than 6 months
  • •no history of any procedural intervention in past 3 months

排除标准

  • •history of keloid, active acne, local infection, skin allergies, hypertrophic scarring, photosensitivity, or history of any comorbidities
  • •history of use of oral isotretinoin, OCPs, steroids or immunosuppressants
  • •pregnant or lactating females

研究组 & 干预措施

Intralesional Saline for acne scars (Group A)

Active Comparator

Intralesional Saline 5 to 10ml injected in the sacrs fortnightly for 3 months

干预措施: Intralesional Saline (Procedure)

Topical Trichloracetic acid for acne scars(Group B)

Active Comparator

35% trichloroacetic acid peel was applied to scars monthly for 3 months

干预措施: 35% trichloracetic acid peel (Procedure)

结局指标

主要结局

Observer Scar Assessment Scale

时间窗: clinical assessment will be done monthly for 6 months

efficacy was labelled as improvement on observer scar assessment scale by \>50% compared to baseline. Patient's satisfaction was recorded as 'not satisfied' (VAS score of 1-5), 'Satisfied' (VAS score of 6-7), and 'very satisfied' (Vas score of 8-10)

次要结局

未报告次要终点

研究者

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

Kainat usman

Post Graduate Resident in Dermatology

Sheikh Zayed Medical College

研究点 (2)

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