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

Sponsor
Assiut University (Other)
Overall Status
Completed
CT.gov ID
NCT03183765
Collaborator
(none)
48
1
2
9
5.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Measles-Mumps-Rubella Vaccine
  • Procedure: cryotherapy
Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Intralesional Measles, Mumps, Rubella (MMR) Vaccine Versus Cryotherapy in Treatment of Multiple Common and Planter Warts : a Randomized Controlled Trial
Actual Study Start Date :
Aug 1, 2017
Actual Primary Completion Date :
Mar 1, 2018
Actual Study Completion Date :
May 1, 2018

Arms and Interventions

Arm Intervention/Treatment
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
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).
Other Names:
  • MMR
  • 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
    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).

    Outcome Measures

    Primary Outcome Measures

    1. Cure rate [60 days]

      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

    1. Detection of partial response to both measures [60 days]

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

    2. Side effects [60 days]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years and Older
    Sexes Eligible for Study:
    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:
    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Assiut university hospitals Assiut Egypt 71515

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    GAbdelsamea, Principal Investigator, Assiut University
    ClinicalTrials.gov Identifier:
    NCT03183765
    Other Study ID Numbers:
    • MMRVCRYO
    First Posted:
    Jun 12, 2017
    Last Update Posted:
    Jun 16, 2020
    Last Verified:
    Jun 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 16, 2020