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临床试验/CTRI/2026/03/106811
CTRI/2026/03/106811尚未招募Phase 3 4

A Comparative Study Evaluating Efficacy Of Combination Therapy Of Intralesional Triamcinolone Acetonide With Fractional CO2 Laser Versus Intralesional Triamcinolone Acetonide With Hyaluronidase In Management Of Keloids

Parul Sevashram Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2026年4月6日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
入组人数
120
试验地点
1

研究概览

简要总结

A comparative study will be carried out at Parul Sevashram hospital which is attached to Parul Institute of Medical Sciences and Research, Parul University, Vadodara on patients presenting with keloids to the outpatient department of Dermatology, venereology and Leprosy and referred from medicine & surgery department. The study will start after taking permission from Institutional Ethics Committee and allotment of CTRI registration number. 

  1. All patients meeting the inclusion and exclusion criteria will be subjected to detailed history and meticulous examination as per proforma after taking informed consent.

 2. Group A (study group): treated with fractional CO2 laser followed by intralesional triamcinolone acetonide. Fractional CO2 laser therapy is given with energy 10-30mJ, depending on scar thickness. Triamcinolone is injected immediately after laser therapy. Sessions every 3 weeks for 4 sessions.

 Group B (study group): treated with hyaluronidase injection along with triamcinolone acetonide: typically 1500 IU equivalent to 50 IU per 1 ml of steroid solution is given intralesionally. Given every 3 weeks for 4 sessions.

 3. Patient will be observed for thirty minutes after completion of procedure. Follow up after 3 months to check for degree of reduction and again after 6 months to check for recurrence.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients aged between 18 to 60 years Patients with clinically diagnosed keloid No prior treatment within the last six months Willingness to participate and provide informed consent.

排除标准

  • Active infection at the lesion site
  • Known hypersensitivity to corticosteroids
  • Immunocompromised individuals or patients on immuno suppressive therapy
  • Pregnant or lactating women.

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Pranjal Palan

Parul institute of medical sciences and research

研究点 (1)

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