A comparative study between intralesional steroid and topical pirfenidone gel vs intralesional steroid monotherapy in the management of keloids : an open label randomised controlled trial in a tertiary care hospital in Eastern India

Institute of Post Graduate Medical Education and Research and SSKM Hospital Kolkata1 个研究点分布在 1 个国家目标入组 72 人开始时间: 2025年9月15日最近更新: 2025年8月13日

试验速览

阶段: Phase 3 4
状态: 尚未招募
发起方
入组人数: 72
试验地点: 1
主要终点: Total maximum score 18 points

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Hemostasis, inflammation, proliferation and remodelling enable wound healing. Scarring occurs when fibrosis is either reduced or excessive. Keloid fibroblasts continue to produce connective tissue beyond the expected period for normal scars and they do not undergo apoptosis. TGF beta regulates fibroblast proliferation and collagen synthesis. Keloids show over production and inadequate regulation of TGF beta activity.

Pirfenidone is an anti fibrotic anti inflammatory drug that causes suppression of keloid derived fibroblast contraction through inhibition of the TGF beta one pathway, serving as a potential therapeutic agent for keloids.

There are various treatments available using both surgical and non surgical techniques however, optimal results are difficult to predict. Intralesional triamcinolone injections are most commonly used worldwide, however they come with numerous side effects such as pain, skin thinning, subcutaneous tissue atrophy, steroid acne, capillary dilation, development of secondary hypopigmentation and high recurrence rates.

Often, a combination therapy works more efficiently than monotherapy in keloids. We aim to combine the positive effects of intralesional triamcinolone and pirfenidone 8 percent gel in better management of the condition and asses if this combination might reduce the side effects seen with steroid monotherapy.

研究设计

研究类型: Interventional
分配方式: Randomized
盲法: Participant and Outcome Assessor Blinded

入排标准

年龄范围: 18.00 Year(s) 至 70.00 Year(s)（—）
性别: All

入选标准

•Patients attending the Dermatology OPD of IPGMER during the study period ages 18 to 70 years with Keloid scars previously not treated by any other methods will be included with informed consent.

排除标准

•Pregnant or lactating females, patients with large Keloid scars that are unsuitable for Intralesional Steroid injections, patients treated previously, patients with bleeding disorders, keloids with secondary infection or ulceration unsuitable for intralesional injections, hypersensitivity or drug allergy to Injection Triamcinolone acetonide or topical pirfenidone 8 percent gel, unwilling patients or patients with high treatment expectations.