| CTRI Number |
CTRI/2017/08/009327 [Registered on: 09/08/2017] Trial Registered Retrospectively |
| Last Modified On: |
19/07/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Usefulness and safety of Mw vaccine versus Mantoux antigen in patients of warts caused by virus |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nilay Kanti Das |
| Designation |
Associate Professor |
| Affiliation |
Department of Dermatology Medical College Kolkata |
| Address |
Department of Dermatology Medical College 88 College Street Kolkata 73 West Bengal
Kolkata
WEST BENGAL
700073
India
Kolkata
WEST BENGAL
700073
India |
| Phone |
9433394148 |
| Fax |
|
| Email |
drdasnilay@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nilay Kanti Das |
| Designation |
Associate Professor |
| Affiliation |
Department of Dermatology Medical College Kolkata |
| Address |
Department of Dermatology Medical College 88 College Street Kolkata 73 West Bengal
Kolkata
WEST BENGAL
700073
India
Kolkata
WEST BENGAL
700073
India |
| Phone |
9433394148 |
| Fax |
|
| Email |
drdasnilay@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Somodyuti Chandra |
| Designation |
Junior Resident |
| Affiliation |
Department of Dermatology Medical College Kolkata |
| Address |
Department of Dermatology Medical College 88 College Street Kolkata 73 West Bengal
Kolkata
WEST BENGAL
700073
India
Kolkata
WEST BENGAL
700073
India |
| Phone |
9051346167 |
| Fax |
|
| Email |
somodyuti.c@gmail.com |
|
|
Source of Monetary or Material Support
|
| Medical College Kolkata 88 College Street Kolkata 700073 |
|
|
Primary Sponsor
|
| Name |
Medical College Kolkata |
| Address |
88 College Street Kolkata - 73 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Nilay Kanti Das |
Medical College, Kolkata |
Department of Dermatology Medical College 88 College Street Kolkata - 73 West Bengal
Kolkata
Kolkata
WEST BENGAL |
9433394148
drdasnilay@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Human Research, Medical College, Kolkata |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Multiple viral warts, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Mycobacterium w (Mw) vaccine |
0.1 ml of Mw vaccine administered intradermally into the volar aspect of forearm using an insulin syringe, at an interval of 2 weeks, for a duration of 12 weeks |
| Intervention |
Purified Protein Derivative (PPD) |
0.1 ml PPD of strength 10TU/0.1ml administered intradermally into the volar aspect of forearm using an insulin syringe, at an interval of 2 weeks, for a duration of 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
i.Male or female patients between 18 and 65 years of age (both inclusive).
ii.Multiple viral warts ≥5.
iii.Patients who give their informed consent
|
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Number of warts |
Baseline, 2, 4, 6, 8, 10, 14, 18, 22 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Serum for Liver Function Test, urea, creatinine, Hemoglobin, Total count, Differential Count, Erythrocyte Sedimentation Rate |
Screening visit, 10 weeks |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/05/2015 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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. |