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CompletedNCT03183765Updated Jun 16, 2020

Intralesional Measles, Mumps, Rubella (MMR) Vaccine Versus Cryotherapy in Treatment of Multiple Common and Planter Warts

A Phase 4 interventional study of Measles-Mumps-Rubella Vaccine and cryotherapy in Common Wart and Plantar Wart, sponsored by Assiut University. Completed at 1 site in Egypt. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2020-06-16.

Sponsored by Assiut University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
16 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Common Wart
  • Plantar Wart

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03

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients should have multiple common or plantar warts.
  • No concurrent systemic or topical treatment of warts

Exclusion criteria

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.
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    MMR vaccine

    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

    Drug: Measles-Mumps-Rubella Vaccine

  • Active comparator
    Cryotherapy

    patients received cryotherapy with liquid nitrogen once every 2 weeks until complete clearance or for a maximum of 3 sessions

    Procedure: cryotherapy

Interventions

  • DrugMeasles-Mumps-Rubella Vaccine

    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).

    Also known as: MMR

  • Procedurecryotherapy

    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).

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 60 days

Secondary outcomes

  1. Detection of partial response to both measures

    if there was a decrease in the size or a decrease in the total number of warts

    Time frame: 60 days

  2. Side effects

    Detection of post procedure side effects such as flu like symptoms, pain , hypopigmentation.

    Time frame: 60 days

06

Study locations

1 site
  • Assiut university hospitals
    Assiut, 71515, Egypt
07

References and documents

Publications

  • 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. PubMed 25847793 ↗
  • 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. PubMed 21812829 ↗
  • 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. PubMed 25070525 ↗
  • 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. PubMed 11295925 ↗
  • 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. PubMed 19878308 ↗
  • 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. PubMed 19112075 ↗
  • 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. PubMed 18577059 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03183765
Lead sponsor
Assiut University
Responsible party
GAbdelsamea (Principal Investigator, Assiut University) — Principal investigator
First posted
Jun 12, 2017
Start date
Aug 1, 2017
Primary completion
Mar 1, 2018
Completion
May 1, 2018
Last update
Jun 16, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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