The Efficacy of Intralesional Bleomycin as Compared to 5-Flourouracil (5-FU) and Triamcinolone Acetonide (TAC) for the Treatment of Keloids: A Randomized Control Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- The Efficacy in terms of POSAS SCAR SCALE of Intralesional Bleomycin as compared to 5-fluorouracil (5-FU) and Triamcinolone Acetonide(TAC) for the treatment of Keloids: A Randomized Control Trial
研究概览
简要总结
The goal of this clinical trial is to learn if drug bleomycin intralesionally is beneficial than intralesional 5FU and Triamcinolone Acetonide in treating Keloids. The main questions it aims to answer are:
Does drug Bleomycin injected intrasleisonally lower the time duration to effectively treat the keloids in participants as compared to intralesional Triamcinolone Acetonide and 5-Flourouracil? Researchers will compare drug Bleomycin and 5FU plus Triamcinolone Acetonide and determine if bleomycin is better.
Participants will:
Treatment will be given in two groups by a researcher blinded of the treatment being given in each group. POSAS patient and observer scar scale will be used to assess the keloids at 0, 2, 4, 6, 8, 10, and 12 weeks and during follow ups afterwards, assessments will be carried out by another researcher who will assess the improvement on the scale of 0-no improvement, to excellent-75-100% improvement in terms of POSAS variables. Effectiveness will be indicated by 50% reduction in POSAS score from the baseline.
详细描述
The goal of this clinical trial is to learn if drug bleomycin intralesionally is beneficial than intralesional 5FU and Triamcinolone Acetonide in treating Keloids. The main questions it aims to answer are:
Does drug Bleomycin injected intrasleisonally lower the time duration to effectively treat the keloids in participants as compared to intralesional Triamcinolone Acetonide and 5-Flourouracil? Researchers will compare drug Bleomycin and 5FU plus Triamcinolone Acetonide and determine if bleomycin is better.
An informed, written consent will be taken from the patients. Clinical data including demographic data will be recorded. Patients will be randomly divided into two groups by using random allocation software 2.0. Group A will be given 1ml if 0.9ml/22.5mg (25mg/ml) of 5-FU with 0.1 ml/4mg (40mg/ml) of Triamcinolone Acetonide, intralesionally 1cm apart, as 0.1- 0.2ml/cm2 with max dose of 5ml per session and repeat after every 2 weeks. Group B will be given injection Bleomycin 1.5 IU /ml (15 units vial dilution in 10ml Normal saline) 1 ml of this 1cm apart intralesionally as 0.1- 0.2ml/cm2 with max dose of 5ml per session and repeat after 2 weeks. Treatment will be given in two groups by a researcher blinded of the treatment being given in each group. POSAS patient and observer scar scale will be used to assess the keloids at 0, 2, 4, 6, 8, 10, and 12 weeks and during follow ups afterwards, assessments will be carried out by another researcher who will assess the improvement on the scale of 0-no improvement, to excellent-75-100% improvement in terms of POSAS variables. Effectiveness will be indicated by 50% reduction in POSAS score from the baseline. All the data will be noted on a specially designed pro forma.
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
- Single (Investigator)
入排标准
- 年龄范围
- 13 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All, patients aged 13-60 years of age, either gender enrolled for Keloid treatment under local anaesthesia.
排除标准
- •Allergic to bleomycin, 5-FU DIABETICS VASCULAR INSUFFICIENCY AT THE AFFECTED SITE
研究组 & 干预措施
The Efficacy of Intralesional Bleomycinin treatment of keloids
Group B will be given injection Bleomycin 1.5 IU /ml (15 units vial dilution in 10ml Normal saline) 1 ml of this 1cm apart intralesionally as 0.1- 0.2ml/cm2 with max dose of 5ml per session and repeat after 2 weeks. Treatment will be given in two groups by a researcher blinded of the treatment being given in each group. POSAS patient and observer scar scale will be used to assess the keloids at 0, 2, 4, 6, 8, 10, and 12 weeks and during follow ups afterwards, assessments will be carried out by another researcher who will assess the improvement on the scale of 0-no improvement, to excellent-75-100% improvement in terms of POSAS variables.
干预措施: intralesional bleomycin (Drug)
The Efficacy of 5-fluorouracil (5-FU) and Triamcinolone Acetonide in treatment of keloids
Group A will be given 1ml if 0.9ml/22.5mg (25mg/ml) of 5-FU with 0.1 ml/4mg (40mg/ml) of Triamcinolone Acetonide, intralesionally 1cm apart, as 0.1- 0.2ml/cm2 with max dose of 5ml per session and repeat after every 2 weeks.
干预措施: 5-flourouracil and triamcinolone acetonide (Drug)
结局指标
主要结局
The Efficacy in terms of POSAS SCAR SCALE of Intralesional Bleomycin as compared to 5-fluorouracil (5-FU) and Triamcinolone Acetonide(TAC) for the treatment of Keloids: A Randomized Control Trial
时间窗: 12 weeks
The observer scale of the POSAS consists of six items (vascularity, Pigmentation, thickness, relief, pliability and surface area). All items are scored on a scale ranging from 1 ('like normal skin') to 10 ('worst scar imaginable').The sum of the six items results in a total score of the POSAS observer scale.
efficacy of intralesional bleomycin and combination of triamcinolone acetonide and 5-flourouracil in treating keloids, comparing the scar reduction in accordance with the patient and observer scar (POSAS) scale in two groups.
时间窗: 4 months
Efficacy will be assessed by comparing the scar reduction on in accordance with the patient and observer scar (POSAS) scale in two groups. 50% reduction in score from baseline indicates that treatment is affective . It will be assessed at twice weekly interval till 12 weeks.
次要结局
未报告次要终点
研究者
Shumaila Dogar
Consultant
King Edward Medical University