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临床试验/CTRI/2024/12/077629
CTRI/2024/12/077629尚未招募不适用

Evaluation of efficacy of intralesional Inj. Vitamin D versus intralesional Inj. Acyclovir in the treatment of recalcitrant cutaneous warts: A randomised clinical trial.

Ashrita Krishna1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年12月14日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Achieving Visual analogue score 4

研究概览

简要总结

Patients with cutaneous warts attending the Outpatient Department of Dermatology were enrolled after obtaining informed written consent with complete history taking and thorough cutaneous examination

Clinico‑demographic details of participants were recorded and clinical,  images were taken at baseline and at each follow‑up visit i.e at 2nd ,4th ,6th, and 8th week .

All patients fulfilling the inclusion criteria will be categorized into two groups depending on the treatment they received, namely, Group A (intralesional Vit D) and Group B (intralesional acyclovir) (n=20 per group ) 1

Group A : Vitamin D3 (0.2mL, 15mg/dl)   injected into the base of the warts after injecting with lidocaine (0.2mL, 15mg/dl).

Group B : Intralesional injection of acyclovir (70 mg/ml), at a dose of 0.1 ml, injected into the base of each wart.

Repeated two weeks apart for a maximum of four sessions or until complete clearance, whichever occureds earlier.

Patients were further followed up for a period of 6  months after treatment completion.

Clinical response documented by recording the decrease in number and size of  lesions at each visit i.e., at 2 weekly intervals for 4 sessions and 3 months after the last injection.

The reduction in the size and number of warts classified the response to treatment into four grades based on the Visual Analogue Scale (VAS) score

研究设计

研究类型
Interventional
分配方式
Other
盲法
None

入排标准

年龄范围
13.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • 1 or more recalcitrant warts (defined here as warts persistent for a period of more than 6 months, resistant to at least 2 conventional treatment modalities) Extragenital warts.
  • Patients willing to give informed written consent for the study.

排除标准

  • Mucosal warts, Pregnancy, lactation, Immunosuppression.

结局指标

主要结局

Achieving Visual analogue score 4

时间窗: week 8

次要结局

  • Visual analogue score 4(week 2,4,6)

研究者

发起方
Ashrita Krishna
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Ashrita Krishna

Hassan Institute Of Medical Sciences

研究点 (1)

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