Evaluation of efficacy of intralesional MMR with Vitamin D3 in cutaneous warts using dermoscopy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- • To determine the efficacy of IL MMR vaccine in the treatment of warts.
研究概览
简要总结
All patients attending DVL OPD at TMU Hospital clinically diagnosed with warts with or without distant warts meeting the inclusion and exclusion criteria to be enrolled in the study. Investigator blinding will be done. Based on computer generated random number table, patients will be assigned to either Group A or Group B and allocation concealment will be done while assigning groups.
A detailed history will be taken and dermatological examination will be done.Dermoscopic evaluation would be done using both polarized and non-polarized mode using Dermlite DL5 dermoscope at baseline and in subsequent treatment session by other investigator. Structured case record form would be used for the purpose of recording of history and examination findings.
All Group A patients will receive intralesional injection of upto 0.5 mL of Inj Vitamin D3(6,00,000IU; 15 mg/ml)into a wart each session after injection of IL lignocaine with 31 G insulin syringe
All Group B patients will receive a intralesional injection of upto of 0.5ml of reconstituted MMR vaccine into wart in each session with 31 G insulin syringe.
Amount of injection on each wart will depend on the size of each wart. The intralesional injection will be given every three weeks for a maximum of 4 doses or until complete resolution, whichever is earlier.
Photographic and Dermoscopic comparison will be used to assess decrease in size and number of warts and thus the response to treatment and clinical response will be noted.
Follow up will be made every monthly for 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 12.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Clinically diagnosed patients of warts attending the Department of Dermatology, Venereology & Leprosy(both out-patient and in-patient)of Teerthankar Mahaveer Medical College,Moradabad(UP)
- •Age from 12 years to 70 years of both sexes 3.Patients giving informed and willing consent.
排除标准
- •1.Patients under any systemic or topical treatment of warts for the last 4 weeks 2.PatientswithapasthistoryofanallergicresponsetoMMRoranyothervaccineorVitaminD3.
结局指标
主要结局
• To determine the efficacy of IL MMR vaccine in the treatment of warts.
时间窗: 3,6,9,12 weeks,1,2,3 months
• To determine the efficacy of IL vitamin D3 in the treatment of warts.
时间窗: 3,6,9,12 weeks,1,2,3 months
• To compare the efficacy of IL MMR vaccine and IL Vitamin D3 during follow up using dermoscopy.
时间窗: 3,6,9,12 weeks,1,2,3 months
To identify various dermoscopic features of warts before and after immunotherapy.
时间窗: 3,6,9,12 weeks,1,2,3 months
次要结局
- To determine the side effects of IL MMR vaccine and IL Vitamin D3 in treatment of warts.(3,6,9,12 weeks,1,2,3 months)
研究者
Ketaki Shaha
Teerthankar Mahaveer Medical College and Research Centre