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临床试验/NCT07420166
NCT07420166已完成不适用

Comparison of the Outcome of Treatment of Intralesional Triamcinolone Acetonide With Intralesional Verapamil Hydrochloride in Patients Presenting With Keloid at Tertiary Care Hospital, Bahawalpur.

Muhammad Aamir Latif1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Scar assessment

研究概览

简要总结

The paucity of local literature regarding the comparison of intralesional verapamil with intralesional triamcinolone acetonide led this study to be carried out with the objective of comparing the clinical effectiveness of intralesional triamcinolone acetonide and intralesional verapamil hydrochloride in patients with keloids.

详细描述

Although the anti-inflammatory and scar-enhancing properties of corticosteroids on hypertrophic scars and keloids have been investigated and documented thoroughly. There are many different treatments for keloids nowadays; each method has its advantages and disadvantages, and the results also vary depending on each study. Moreover, local data to address this issue is also scarce. The findings of this study would not add to the existing stats, but comparing the outcomes of both the drugs would also guide clinicians towards better management of keloids by choosing the more appropriate treatment.

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
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Either gender
  • Aged between 20 and 60 years
  • With keloids
  • Benign dermal growths
  • Scar length not exceeding 5 centimeters
  • Keloid duration of five years or less
  • A baseline Vancouver Scar Scale score of 5 or more

排除标准

  • Pregnant or lactating women
  • A family history of keloids
  • Diagnosed with conditions such as acromegaly, diabetes mellitus, or congestive cardiac disease
  • a history of thyroidectomy
  • Current or recent use of isotretinoin or anabolic steroids, as determined by history, physical examination, blood glucose analysis, and electrocardiography

研究组 & 干预措施

Triamcinolone Group

Experimental

Patients received intralesional triamcinolone acetonide (20 mg/mL) at a volume not exceeding 1.5 cc per session every three weeks, for a maximum of eight sessions or until complete scar flattening. Each injection session was preceded by 20 seconds of cryotherapy using cryospray applied at a distance of one centimeter from the lesion.

干预措施: Triamcinolone Acetonide (Drug)

Verapamil Group

Experimental

Patients were managed with intralesional verapamil hydrochloride (2.5 mg/ml) at a volume not exceeding 1.5 cc per session every three weeks, for a maximum of eight sessions or until complete scar flattening. Each injection session was preceded by 20 seconds of cryotherapy using cryospray applied at a distance of one centimeter from the lesion.

干预措施: Verapamil Hydrochloride (Drug)

结局指标

主要结局

Scar assessment

时间窗: 24 weeks

Using the Vancouver Scar Scale, height, vascularity, pliability, and pigmentation were assessed at baseline and compared with post-treatment measures at 24 weeks. A score closer to 0 was deemed as better vascularity (not red), low pigmentation, high pliability (soft), and low thickness.

次要结局

未报告次要终点

研究者

发起方
Muhammad Aamir Latif
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Muhammad Aamir Latif

Research Consultant

RESnTEC, Institute of Research

研究点 (1)

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