Comparative study of therapeutic efficacy and safety of intralesional steroid (40mg/ml) vs fractional CO2 laser (10-60W with a pulse duration of 100 microseconds to 10 milliseconds) in keloids
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- To study the therapeutic efficacy of intralesional steroid 40mg/mL in dilution with lignocaine compared to fractional CO2 laser 10 to 60 W with a pulse duration of 100 microseconds to 10 milliseconds among keloid patients.
研究概览
简要总结
A total of 48 patients presenting to Department of Dermatology , Eras Lucknow Medical College and Hospital, Lucknow of Keloid will be approached for participation in the study.
Patients meeting inclusion and exclusion criteria and giving written consent for participating in the study shall be recruited. History and clinical examination with photographic documentation and KASI (Keloid Area Severity Index) score and JSW (Japan Scar Workshop) score will be done before starting treatment and then at each visit. Patients will be randomly divided into two groups -A and B , each containing 24 indivisuals. In group A - Patients will be given intralesional triamcinolone acetonide 40mg/ml at 0, 3 ,6 ,9 and 12 weeks and at each follow up visit clinical response will be determined by KASI and JSW scores. Based on KASI and JSW scores the therapeutic efficacy is graded.
If at any point , any patient withdraws the consent during the study or does not come for 2 consecutive follow ups despite telephonic reminder he/she shall be considered dropped out of the study.
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
- 0.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Keloid patients attending dermatology OPD at Eras Lucknow Medical College and Hospital.
排除标准
- •1.Keloid near vital structures.
- •2.Active infection at keloid site 3.Pregnancy and lactation 4.Photosensitivity.
结局指标
主要结局
To study the therapeutic efficacy of intralesional steroid 40mg/mL in dilution with lignocaine compared to fractional CO2 laser 10 to 60 W with a pulse duration of 100 microseconds to 10 milliseconds among keloid patients.
时间窗: 0,3,6,9,12 weeks
次要结局
- To study the safety of intralesional steroid 40mg/mL compared to fractional CO2 laser 10 to 60 W with a pulse duration of 100 microseconds to 10 milliseconds compared to co2 laser among keloid patients.
研究者
Bushra shahid
Eras Lucknow Medical College and Hospital