Usefulness and safety of Mw vaccine versus Mantoux antigen in patients of warts caused by virus

Active, not recruiting

Conditions: Multiple viral warts

Registration Number: CTRI/2017/08/009327

Lead Sponsor: Medical College Kolkata

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Closed to Recruitment of Participants

Sex: All

Target Recruitment: 64

Inclusion Criteria

i.Male or female patients between 18 and 65 years of age (both inclusive).
ii.Multiple viral warts â‰¥5.
iii.Patients who give their informed consent.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of warts	Baseline, 2, 4, 6, 8, 10, 14, 18, 22 weeks

Secondary Outcome Measures

Name	Time	Method
Serum for Liver Function Test, urea, creatinine, Hemoglobin, Total count, Differential Count, Erythrocyte Sedimentation Rate	Screening visit, 10 weeks

Trial Locations

Locations (1): Medical College, Kolkata
🇮🇳
Kolkata, WEST BENGAL, India
Medical College, Kolkata
🇮🇳Kolkata, WEST BENGAL, India
Nilay Kanti Das
Principal investigator
9433394148
drdasnilay@gmail.com