Evaluating The Efficacy and Safety of CO2 Laser-Assisted Drug Delivery of Pirfenidone Combined with Intralesional Triamcinolone Acetonide (ILTAC) Versus CO2 Laser With ILTAC Alone in Keloid.
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
研究概览
简要总结
Keloids are raised scars that extend beyond the original wound because of excessive collagen production during healing. Beyond their appearance, they can cause itching, pain, and restricted movement, leading to distress, self-consciousness, and a significant reduction in quality of life and psychological well-being. Standard keloid management often involves intralesional triamcinolone acetonide injections, which help suppress fibroblast activity and collagen production. However, recurrences are common, and repeated injections may cause skin atrophy, telangiectasia, and perilesional hypopigmentation. Even after satisfactory volume reduction, the overlying skin surface often remains irregular and cosmetically unsatisfactory. Fractional CO2 laser allows controlled remodeling of scar tissue and may improve texture to some extent; however, monotherapy remains insufficient for achieving sustained and comprehensive improvement. Combination approaches are needed to reduce the adverse effects associated with repeated steroid injections, address the risk of recurrence, and improve overall treatment outcomes. Pirfenidone, an orally approved antifibrotic, downregulates TGF beta 1, PDGF, and TNF alpha, thereby curbing fibroblast proliferation and collagen type I deposition. In keloid management, early clinical studies have shown promising results with the topical formulation, eight percent pirfenidone gel, in improving pathological scars. Combination of fractional CO2 laser with eight percent pirfenidone gel may modulate the early pro-fibrotic wound phase, promote organized collagen remodeling, and potentially yield superior outcomes compared with fractional CO2 laser and triamcinolone acetonide alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 15.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients of either gender aged 15–60 years with clinically diagnosed keloids measuring 2–10 cm in largest diameter, who are treatment-naïve and have stable lesions for at least 6 months, located on the trunk, extremities, or neck.
排除标准
- •1.Patients with infected keloids or coexisting inflammatory systemic skin diseases 2.Unrealistic expectations or psychiatric illnesses 3.Pre existing bleeding disorders 4.Lactating/pregnant patients.
研究者
Dr Madura C
CUTIS Academy of Cutaneous Sciences
