Clinical trial NCT03183765: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Common Wart
Plantar Wart
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-06-12
Enrollment: 48
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Cure rate
timeFrame: 60 days
Secondary outcomes:
measure: Detection of partial response to both measures
timeFrame: 60 days
measure: Side effects
timeFrame: 60 days
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university hospitals
Study officials:
References:
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.
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.
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.
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.
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.
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.
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.