Usefulness and safety of vaccine for Mumps-Measles-Rubella in the treatment of wart(s) caused by viruses
- Conditions
- Multiple viral warts
- Registration Number
- CTRI/2018/03/012515
- Lead Sponsor
- Medical College Kolkata
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- All
- Target Recruitment
- 38
- 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.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction in the size and total number of lesions- Baseline, 2, 4, 8, 12, 16, 20, 24, 28 weeks a.Complete removal Baseline, 2, 4, 8, 12, 16, 20, 24, 28 weeks c.No response Baseline, 2, 4, 8, 12, 16, 20, 24, 28 weeks b.Partial clearance Baseline, 2, 4, 8, 12, 16, 20, 24, 28 weeks
- Secondary Outcome Measures
Name Time Method Serum for Liver Function Test, Urea, Creatinine, Hemoglobin, Total count, Differential Count, Erythrocyte Sedimentation Rate, Fasting blood sugar Screening visit, 4 weeks
Trial Locations
- Locations (1)
Medical College, Kolkata
🇮🇳Kolkata, WEST BENGAL, India
Medical College, Kolkata🇮🇳Kolkata, WEST BENGAL, IndiaDr Ramesh Chandra GharamiPrincipal investigator9434173114rameshgharami8@gmail.com