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
|
|
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
|
|
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. |