A double blind, randomized controlled trial to compare the effectiveness and safety of Purified Protein Derivative (PPD) of Tuberculin Antigen with Mycobacterium w (Mw) vaccine in the treatment of multiple viral warts
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Number of warts
研究概览
简要总结
Viral warts are a common dermatological problem caused by humanb Papilloma Virus (HPV). They are pleomorphic affecting a wide variety of sites, principally skin of extremities, genitall skin and mucosa, larynx and oral mucosa. Management of verrucae, primarily over periungual areas and over soles is often frustrating, to the patient and the physician alike. Primary treatment modalities include destructive therapies like topical chemical cautery, cryotherapy, electro-cautery, excision, bleomycin sulphate injection etc, but none of them give guarantee of cure and recurrence is common, apart from scarring associated with these modalities.To overcome these challenges, many immunotherapeutic modalities including PPD, Mw vaccine have been investigated.
This study is designed as a single centre, prospective, interventional, parallel arm, randomised (1:1), actively controlled trial. The baseline visit will be scheduled 3 days after screening visit. Every patient will be given intradermal injection of PPD or Mw vaccine according to randomisation every two weekly for a total of six injections or less in case of resolution of warts. The patients will be followed up for 3 months after treatment completion to look for any recurrence. Photographic documentation will be done before the procedure and then periodically.
At all the follow-ups, the effectiveness and safety parameters will be noted. DLQI will be filled up at baseline, at end of treatment visit and at end of cure visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •i.Male or female patients between 18 and 65 years of age (both inclusive).
- •ii.Multiple viral warts ≥
- •iii.Patients who give their informed consent.
排除标准
- •i.Pregnant and lactating women.
- •ii.Any evidence of immunosuppression (eg.
- •HIV infection, organ transplantation, long term steroid use etc.).
- •iii.Any other systemic disease (eg.
- •liver or kidney disorder).
- •iv.Presence of mucosal wart(s).
- •v.Presence of ulcerated or inflamed wart(s).
- •vi.Patients who participated in a clinical trial in the last three months.
结局指标
主要结局
Number of warts
时间窗: Baseline, 2, 4, 6, 8, 10, 14, 18, 22 weeks
次要结局
- Serum for Liver Function Test, urea, creatinine, Hemoglobin, Total count, Differential Count, Erythrocyte Sedimentation Rate(Screening visit, 10 weeks)
