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CTRI Number  CTRI/2018/03/012515 [Registered on: 13/03/2018] Trial Registered Retrospectively
Last Modified On: 09/03/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Vaccine 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Usefulness and safety of vaccine for Mumps-Measles-Rubella in the treatment of wart(s) caused by viruses 
Scientific Title of Study   Efficacy and safety of intralesional Mumps-Measles-Rubella vaccine in the treatment of viral wart(s): A Double Blind, Placebo Controlled Randomised Clinical Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ramesh Chandra Gharami 
Designation  Professor 
Affiliation  Medical College, Kolkata 
Address  Department of Dermatology Medical College, Kolkata 88 College Street, Kolkata 73 West Bengal India

Kolkata
WEST BENGAL
700073
India 
Phone  9434173114  
Fax    
Email  rameshgharami8@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ramesh Chandra Gharami 
Designation  Professor 
Affiliation  Medical College, Kolkata 
Address  Department of Dermatology Medical College, Kolkata 88 College Street, Kolkata 73 West Bengal India

Kolkata
WEST BENGAL
700073
India 
Phone  9434173114  
Fax    
Email  rameshgharami8@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Arini Banerjee 
Designation  Junior Resident 
Affiliation  Medical College, Kolkata 
Address  Department of Dermatology Medical College, Kolkata 88 College Street, Kolkata 73 West Bengal India

Kolkata
WEST BENGAL
700073
India 
Phone  9836249115  
Fax    
Email  arini.banerjee2009@gmail.com  
 
Source of Monetary or Material Support  
Medical College Kolkata 88 College Street Kolkata - 700073 West Bengal India 
 
Primary Sponsor  
Name  Medical College Kolkata 
Address  88 College Street Kolkata 700073 West Bengal India 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ramesh Chandra Gharami  Medical College, Kolkata  Out Patient Department (O.P.D) of Dermatology Medical College Kolkata 88 College Street Kolkata 73 West Bengal India
Kolkata
WEST BENGAL 
9434173114

rameshgharami8@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Multiple viral warts,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  MMR vaccine  MMR vaccine 0.3 mL TRESIVAC® (Measles, Mumps and Rubella Vaccine (Live) I.P.) , manufactured by Serum Institute of India, Ltd. freeze-dried is prepared from live attenuated strains of Edmonston-Zagreb Measles virus propagated on human diploid cell culture, L-Zagreb Mumps virus propagated on chick embryo fibroblast cells and Wistar RA 27/3 Rubella virus propagated on human diploid cell culture. The reconstituted vaccine contains, in single dose of 0.5 ml not less than 1000 CCID50 of Measles virus 5000 CCID50 of Mumps virus 1000 CCID50 of Rubella virus. Diluent : Sterile water for injection.  
Comparator Agent  Normal saline  Normal saline 0.3 mL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  i. Patients having clinically diagnosed wart(s).
ii. Patients who give their informed consent.
iii. Patients not having received any anti-wart treatment in the past 4 weeks
iv. Lack of viral diseases such as herpes and/or bacterial infections such as impetigo.
 
 
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. Presence of wart(s) in face proper.
vii. Patients who participated in a clinical trial in the last three months.
viii. Patients not giving consent
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction in the size and total number of lesions-
a. Complete removal
b. Partial clearance
c. No response
 
Baseline, 2, 4, 8, 12, 16, 20, 24, 28 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Serum for Liver Function Test, Urea, Creatinine, Hemoglobin, Total count, Differential Count, Erythrocyte Sedimentation Rate, Fasting blood sugar  Screening visit, 4 weeks 
 
Target Sample Size   Total Sample Size="38"
Sample Size from India="38" 
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)   12/05/2016 
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)   Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   Not published 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Common warts, also called verruca vulgaris is a common dermatological problem, characterized by hyperkeratotic papillomas caused by infection with Human Papilloma Virus (HPV).There are over 118 types of HPV viruses,some of which are implicated in the causation of warts. Warts are of many types and are ubiquitous when it comes to the sites of affection,though they mainly affect the skin of extremities, genital skin and mucosa, larynx and oral mucosa.These are notorious for their infectivity,because any disturbance of epidermal barrier by mild abrasions and maceration is enough to cause infection of the basal keratinocyte with the virus. Spontaneous regression of warts has been seen in two third of cases, yet patients seek treatment because of cosmetic blotch, pain and increase in the number of warts. Many destructive treatment modalities have been explored like topical chemical cautery, cryotherapy, electro-cautery, excision, bleomycin sulphate injection, laser vapourisation and photodynamic therapy ,but none can gurantee a cure and cessation of recurrences.Some of them are costly and can produce side effects like scarring and pain. Considering the fact that despite years of medical research and volumes of literature on this subject, no treatment has yet proven effective for a cure, is exasperating to both the dermatologists’ and patients’ front. In an attempt to overcome the challenges of treatment modalities,as mentioned above,immunotherapy is being researched into as an upcoming and promising field in the treatment of warts.And the rationale behind that being-it has been found that the principal mechanism for the rejection of warts is by cell mediated immunity.Warts can regress when immune response is stimulated and on the other hand it has been noted that prevalence,severity of warts and the incidence of HPV related malignancies increases during the persistant fall of Cell Mediated Immunity(eg HIV). The immunotherapy being researched into are bivalent and quadrivalent HPV vaccines, topical contact sensitizers like Diphencyprone(DPCP), Squaric Acid Dibutyl Ester( SADBE), immunomodifier like imiquimod, antigens like Bacillus Calmette Guerin(BCG), Purified Protein Derivative (PPD), candida, trichophytin, mumps, Mumps-Measles-Rubella(MMR), Mycobacterium w vaccine and interferons.

         The Measles-Mumps-Rubella vaccine is a mixture of live attenuated viruses causing these three diseases, administered via subcutaneous injection to immunocompetant children in two doses with a gap of one month to stimulate their immunity so as to prevent the development of these diseases later on in their life.Intralesional MMR vaccine in the treatment of wart(s) has been found to be effective.

       This study is undertaken to evaluate the effectiveness of intralesional MMR vaccine versus placebo(normal saline) in the treatment of wart(s). This study is designed as a single centre, prospective, interventional, parallel arm, randomised (1:1), placebo controlled trial.  The baseline visit will be scheduled 4 days after screening visit. Every patient will be given intralesional injection of MMR vaccine or placebo according to randomisation every two weekly for a total of three 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.

 
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