Intralesional Measles, Mumps, Rubella (MMR) Vaccine Versus Cryotherapy in Treatment of Multiple Common and Planter Warts
Primary Purpose
Common Wart, Plantar Wart
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Measles-Mumps-Rubella Vaccine
cryotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Common Wart
Eligibility Criteria
Inclusion Criteria:
- Patients should have multiple common or plantar warts.
- No concurrent systemic or topical treatment of warts
Exclusion Criteria:
patients under 16 years old.
• Patients with fever or signs of any inflammation or infection.
- Patients with other types of warts.
Patients with single warts.
- Pregnancy.
- Lactation.
- Immunosuppression.
- Patients who received any other treatments for their warts in the month before starting study.
- Past history of asthma, allergic skin disorders, meningitis or convulsions.
Sites / Locations
- Assiut university hospitals
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
MMR vaccine
Cryotherapy
Arm Description
Measles-Mumps-Rubella Vaccine will be injected 0.5 ml into the largest wart at 2-week intervals until complete clearance was achieved or for a maximum of 3 treatments
patients received cryotherapy with liquid nitrogen once every 2 weeks until complete clearance or for a maximum of 3 sessions
Outcomes
Primary Outcome Measures
Cure rate
Assess cure rate of MMR vaccine and cryotherapy in treatment of common and planter warts (complete disappearance of lesions) one month after last session, compare efficacy of both measures.
Secondary Outcome Measures
Detection of partial response to both measures
if there was a decrease in the size or a decrease in the total number of warts
Side effects
Detection of post procedure side effects such as flu like symptoms, pain , hypopigmentation.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03183765
Brief Title
Intralesional Measles, Mumps, Rubella (MMR) Vaccine Versus Cryotherapy in Treatment of Multiple Common and Planter Warts
Official Title
Intralesional Measles, Mumps, Rubella (MMR) Vaccine Versus Cryotherapy in Treatment of Multiple Common and Planter Warts : a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
March 1, 2018 (Actual)
Study Completion Date
May 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Warts are benign epidermal tumors caused by human papilloma virus, which are epitheliotropic non-enveloped double stranded DNA viruses. Transmission of warts occurs from direct person-to-person contact or indirectly by fomites . Warts appear in various forms including verruca vulgaris, plane, plantar, filiform, digitate and periungual.
Detailed Description
Treatment of warts is difficult for patients and physicians . Currently Available treatment options include cryosurgery, laser, electrosurgery, bleomycin, and topical keratolytic applications; many of them are painful, ineffective, costly and prone for recurrences.
Cryotherapy, which uses liquid nitrogen to freeze tissues and destroy warts, is one of the most common and effective treatments. freezing causes local irritation, leading the host to mount an immune reaction against the virus.
Immunotherapy appears to enhance virus recognition by immune system; allowing clearance of treated wart, distant warts , and helps to prevent infection .Recently, intralesional immunotherapy using different antigens such as mumps, Candida, and tuberculin has been proved effective in the treatment of warts.
The exact mechanism of action of intralesional immunotherapy is still obscure. Intralesional antigen injection probably induces strong non specific inflammatory response against the human papilloma virus-infected cells.
It has been suggested that intralesional measles mumps rubella vaccine results in regression of warts via induction of immune system.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Common Wart, Plantar Wart
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MMR vaccine
Arm Type
Experimental
Arm Description
Measles-Mumps-Rubella Vaccine will be injected 0.5 ml into the largest wart at 2-week intervals until complete clearance was achieved or for a maximum of 3 treatments
Arm Title
Cryotherapy
Arm Type
Active Comparator
Arm Description
patients received cryotherapy with liquid nitrogen once every 2 weeks until complete clearance or for a maximum of 3 sessions
Intervention Type
Drug
Intervention Name(s)
Measles-Mumps-Rubella Vaccine
Other Intervention Name(s)
MMR
Intervention Description
MMR vaccine will be injected 0.5 ml into the largest wart at 2-week intervals until complete clearance was achieved or for a maximum of 3 treatments.
Response to treatment will be evaluated 1 month after the last session by decrease in the size of warts, decrease in the number of warts and photographic comparison. The clinical response was graded into complete (complete cure), partial (if there was a decrease in the size and\or a decrease in the total number of warts), and no response (no change in size and number of warts).
Intervention Type
Procedure
Intervention Name(s)
cryotherapy
Intervention Description
patients received cryotherapy with liquid nitrogen once every 2 weeks until complete clearance or for a maximum of 3 sessions.Response to treatment will be evaluated 1 month after the last session by decrease in the size of warts, decrease in the number of warts and photographic comparison.
The clinical response was graded into complete (complete cure), partial (if there was a decrease in the size and\or a decrease in the total number of warts), and no response (no change in size and number of warts).
Primary Outcome Measure Information:
Title
Cure rate
Description
Assess cure rate of MMR vaccine and cryotherapy in treatment of common and planter warts (complete disappearance of lesions) one month after last session, compare efficacy of both measures.
Time Frame
60 days
Secondary Outcome Measure Information:
Title
Detection of partial response to both measures
Description
if there was a decrease in the size or a decrease in the total number of warts
Time Frame
60 days
Title
Side effects
Description
Detection of post procedure side effects such as flu like symptoms, pain , hypopigmentation.
Time Frame
60 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients should have multiple common or plantar warts.
No concurrent systemic or topical treatment of warts
Exclusion Criteria:
patients under 16 years old.
• Patients with fever or signs of any inflammation or infection.
Patients with other types of warts.
Patients with single warts.
Pregnancy.
Lactation.
Immunosuppression.
Patients who received any other treatments for their warts in the month before starting study.
Past history of asthma, allergic skin disorders, meningitis or convulsions.
Facility Information:
Facility Name
Assiut university hospitals
City
Assiut
ZIP/Postal Code
71515
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25847793
Citation
Shaheen MA, Salem SA, Fouad DA, El-Fatah AA. Intralesional tuberculin (PPD) versus measles, mumps, rubella (MMR) vaccine in treatment of multiple warts: a comparative clinical and immunological study. Dermatol Ther. 2015 Jul-Aug;28(4):194-200. doi: 10.1111/dth.12230. Epub 2015 Apr 6.
Results Reference
background
PubMed Identifier
21812829
Citation
Tomson N, Sterling J, Ahmed I, Hague J, Berth-Jones J. Human papillomavirus typing of warts and response to cryotherapy. J Eur Acad Dermatol Venereol. 2011 Sep;25(9):1108-11. doi: 10.1111/j.1468-3083.2010.03906.x. Epub 2010 Nov 25.
Results Reference
background
PubMed Identifier
25070525
Citation
Nofal A, Nofal E, Yosef A, Nofal H. Treatment of recalcitrant warts with intralesional measles, mumps, and rubella vaccine: a promising approach. Int J Dermatol. 2015 Jun;54(6):667-71. doi: 10.1111/ijd.12480. Epub 2014 Jul 29.
Results Reference
background
PubMed Identifier
11295925
Citation
Johnson SM, Roberson PK, Horn TD. Intralesional injection of mumps or Candida skin test antigens: a novel immunotherapy for warts. Arch Dermatol. 2001 Apr;137(4):451-5.
Results Reference
background
PubMed Identifier
19878308
Citation
Sapp M, Bienkowska-Haba M. Viral entry mechanisms: human papillomavirus and a long journey from extracellular matrix to the nucleus. FEBS J. 2009 Dec;276(24):7206-16. doi: 10.1111/j.1742-4658.2009.07400.x.
Results Reference
background
PubMed Identifier
19112075
Citation
Castellsague X, Cohet C, Puig-Tintore LM, Acebes LO, Salinas J, San Martin M, Breitscheidel L, Remy V. Epidemiology and cost of treatment of genital warts in Spain. Eur J Public Health. 2009 Jan;19(1):106-10. doi: 10.1093/eurpub/ckn127. Epub 2008 Dec 26.
Results Reference
background
PubMed Identifier
18577059
Citation
Choi MH, Seo SH, Kim IH, Son SW. Comparative study on the sustained efficacy of diphencyprone immunotherapy versus cryotherapy in viral warts. Pediatr Dermatol. 2008 May-Jun;25(3):398-9. doi: 10.1111/j.1525-1470.2008.00696.x.
Results Reference
background
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Intralesional Measles, Mumps, Rubella (MMR) Vaccine Versus Cryotherapy in Treatment of Multiple Common and Planter Warts
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