Efficacy of Intralesional Bevacizumab Versus Intralesional Triamcinolone Acetonide Injection in the Treatment of Keloids.
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Modified Vancouver scar scale (mVSS)
研究概览
简要总结
The study compares the efficacy and safety of intralesional bevacizumab versus corticosteroids for the treatment of keloids. Assessment will be done clinically by the use of Modified Vancouver Scar Scale. Erythema index will be measured by spectrophotometry. The levels of Vascular Endothelial Growth Factor, collagen type 1 and collagen type 3 in the lesions before and after each treatment modality.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with keloids (post-traumatic, any site, any duration)
- •Age >18 years
- •Patients who didn't receive any treatment for the lesions in the past 6 weeks
排除标准
- •Patients who are pregnant, willing to get pregnant or lactating
- •History of any liver or renal disease
- •History of any cardiovascular disease
- •History of hypertension
- •History of thrombo-embolic events
- •Known cases of bleeding disorders
- •History of peptic ulcer
- •Patients who underwent any surgeries in the last month
研究组 & 干预措施
Intralesional bevacizumab injection
Intralesional bevacizumab injection for the treatment of keloid
干预措施: Bevacizumab (Drug)
Intralesional corticosteroid injection
Intralesional triamcinolone acetonide injection for the treatment of keloids
干预措施: Triamcinolone Acetonide (Drug)
结局指标
主要结局
Modified Vancouver scar scale (mVSS)
时间窗: 6 months
Six characteristics of the scar were assessed. These are: vascularity, height, pliability, and pigmentation, pain and pruritis. Each characteristic is given a score, which are added together to give an overall score between 0 and 18. Higher scores mean a worse outcome.
Erythema Index
时间窗: 6 months
Evaluation of skin erythema index was done using a spectrophotometry device
Vascular Endothelial growth factor (VEGF)
时间窗: 6 months
Tissue levels of VEGF, collagen type 1 and 3 measured by Enzyme linked immunosorbent assay
Collagen type 1 and 3
时间窗: 6 months
Tissue levels of collagen type 1 and 3 measured by Enzyme linked immunosorbent assay
Histopathological examination
时间窗: 6 months
Two mm punch biopsies were obtained per area at baseline and one month after the last treatment session. The post-treatment biopsy 3as taken from the vicinity of the baseline biopsy. Tissues are fixed in 10% buffered formalin, embedded in paraffin and sectioned into 5 μm-thick sections. Specimens were stained with hematoxylin and eosin (H\&E) and orcein (or demonstration of elastic fibers). Histological examination was carried out under a light microscopy. Assessment was done as follows: 1. Assessment of the collagen fibers will be done by examining H \& E slides, putting grading from 1 to 4 according to the thickness and orientation of the collagen fibers and the spaces in between the fibers. 2. Assessment of the elastic fibers will be done through examining orcein stained specimens and grading the elastic fibers in the scars from 1 to 4 based on presence or absence of the elastic fiber and degree of degradation and fragmentation.
次要结局
未报告次要终点
研究者
Rana F Hilal, MD
Assistant professor
Kasr El Aini Hospital