ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03183765
Recruitment Status : Recruiting
First Posted : June 12, 2017
Last Update Posted : February 23, 2018
Sponsor:
Information provided by (Responsible Party):
GAbdelsamea, Assiut University

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
Common Wart Plantar Wart 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 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 : August 1, 2017
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : April 1, 2019


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 by photographing the patients before treatment and 2 weeks after each session. The clinical response was graded into complete (complete cure), partial (if there was a decrease in the size or a decrease in the total number of warts), and no response (no change in size and number of warts).

Other Name: 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 by photographing the patients before treatment and 2 weeks after each session. The clinical response was graded into complete (complete cure), partial (if there was a decrease in the size or a decrease in the total number of warts), and no response (no change in size and number of warts).





Primary Outcome Measures :
  1. Cure rate [ Time Frame: 45 days ]
    Assess cure rate of MMR vaccine and cryotherapy in treatment of common and planter warts (complete disappearance of lesions) in 45 days duration and compare efficacy of both measures.


Secondary Outcome Measures :
  1. Detection of partial response to both measures [ Time Frame: 45 days ]
    if there was a decrease in the size or a decrease in the total number of warts

  2. Side effects [ Time Frame: 45 days ]
    Detection of post procedure side effects such as flu like symptoms, pain , hypopigmentation.

  3. Number of sessions [ Time Frame: 45 days ]
    Detection of number of sessions needed for cure



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03183765


Contacts
Contact: Ensaf abd el-mageed, PhD 002 01005521529 ensaf.khalil@med.au.edu.eg
Contact: Hisham Gaber, PhD 002 01009535577 Hishamdiabg@yahoo.com

Locations
Egypt
Assiut university hospitals Recruiting
Assiut, Egypt, 71515
Contact: Mohammed M ElSharkawy, PhD    +20 882350177    med_vdgrad@aun.edu.eg   
Sponsors and Collaborators
Assiut University

Publications:

Responsible Party: GAbdelsamea, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03183765     History of Changes
Other Study ID Numbers: MMRVCRYO
First Posted: June 12, 2017    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
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:
Papillomavirus Infections
Warts
Rubella
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases
Rubivirus Infections
Togaviridae Infections
RNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs