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Efficacy of Intralesional MMR Vaccine,Intralesional Candidal Antigen&Topical Podophyllin in Treatment of Genital Warts

Primary Purpose

Condylomata Acuminata

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MMR vaccine
Candida antigen
Topical Podophyllin
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Condylomata Acuminata

Eligibility Criteria

3 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with anogenital warts with ages ranging from 3 to 50 years
  • Genital warts resistant to treatment
  • Genital warts that had relapsed at least once after treatment with any of the tissue-destructive modalities.

Exclusion Criteria:

  • Patients with any evidence of immunosuppression
  • Eczematous skin disorder
  • Those with any history of hypersensitivity to Candida albicans antigen
  • Pregnant or lactating women.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Intralesional MMR vaccine

    intralesional candida antigen

    Topical Podophyllin

    Arm Description

    Intralesional Mumps, measles and rubella (MMR) vaccine in genital warts

    intralesional candida antigen in genital warts

    Topical Podophyllin in genital warts

    Outcomes

    Primary Outcome Measures

    Cure rate
    Assess cure rate of MMR vaccine and candida antigen and topical podophyllin in treatment of genital warts (complete disappearance of lesions) in 45 days duration and compare efficacy of the measures.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 22, 2019
    Last Updated
    March 11, 2019
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03853785
    Brief Title
    Efficacy of Intralesional MMR Vaccine,Intralesional Candidal Antigen&Topical Podophyllin in Treatment of Genital Warts
    Official Title
    The Efficacy of Intralesional Measles, Mumps, Rubella (MMR) Vaccine, Intralesional Candidal Antigen and Topical Podophyllin in Treatment of Genital Warts: A Comparative Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2020 (Anticipated)
    Primary Completion Date
    February 2021 (Anticipated)
    Study Completion Date
    December 2021 (Anticipated)

    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

    5. Study Description

    Brief Summary
    This study compares the safety and efficacy of intralesional Candidal antigen versus Intralesional MMR vaccine versus podophyllin for treatment of genital warts.
    Detailed Description
    Anogenital human papillomavirus (HPV) is a highly prevalent sexually transmitted infection ,seen predominantly in young adults. Condyloma acuminata or benign anogenital warts are typically caused by HPV-6 OR 11 which are considered low risk types.Persistent infection with high risk HPV types predominantly HPV-16 and 18 is the primary and major cause of cervical cancers and a subset of vaginal,vulvar, penile , anal ,oropharyngeal and rarely squamous cell carcinoma of the digits. Warts may reflect a localized or systemic cell-mediated immune (CMI) deficiency to HPV. Anogenital warts may appear as a single lesion or in clusters as flat, flesh-coloured to pigmented plaques or rough-surfaced papules and exophytic nodules. The conventional modalities in treatment of warts include destructive therapies such as salicylic acid, trichloroacetic acid, cryotherapy, silver nitrate, phenol, cantharidin, surgical interventions and lasers; antiproliferative agents such as bleomycin, podophyllin, podophyllotoxin, and 5-fluro uracil; antiviral agents such as cidofovir and retinoids. Because of the cumbersome nature of these procedures and a high risk of recurrence, immunotherapy is becoming more and more popular, especially in the treatment of refractory cutaneous and genital warts.It enhances recognition of the virus by the immune system. immunotherapy not only causes a resolution of the treated wart but also leads to clearance of distant warts, at least in a subset of the responders. Immunotherapy in warts can be administered by various methods. The first method is topical application of certain inorganic molecules that are capable of eliciting a contact hypersensitivity reaction with secondary activation of an immunological response .or even topical applications of immune modulators like imiquimod,A second modality is the use of oral immune modulators such as cimetidine,and levamisole . A third method is Intralesional injection of immunotherapeutic agent that utilizes the ability of the immune system to mount a delayed type hypersensitivity response to various antigens and also the wart tissue leading to production of Th1 cytokines which activate cytotoxic and natural killer cells to eradicate HPV infection. Immunotherapy with different skin test antigens like Candida, mumps or trichophyton antigen is a relatively new treatment option for warts. Candida antigen reported success in majority of patients treated with this test antigen . Mumps, measles and rubella (MMR) vaccine is a freeze-dried preparation of live attenuated strains of measles, mumps and rubella viruses (0.5 ml/dose). In some of the previous studies, it has been shown that mumps-measles-rubella (MMR) vaccine results in regression of warts via immunomodulation and induction of immune system.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Condylomata Acuminata

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    45 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intralesional MMR vaccine
    Arm Type
    Active Comparator
    Arm Description
    Intralesional Mumps, measles and rubella (MMR) vaccine in genital warts
    Arm Title
    intralesional candida antigen
    Arm Type
    Active Comparator
    Arm Description
    intralesional candida antigen in genital warts
    Arm Title
    Topical Podophyllin
    Arm Type
    Active Comparator
    Arm Description
    Topical Podophyllin in genital warts
    Intervention Type
    Biological
    Intervention Name(s)
    MMR vaccine
    Intervention Description
    Intralesional injection of 0.5 ml MMR vaccine in the largest lesion . Injections will be repeated into the same lesion every 2 weeks for a maximum of three treatment sessions.
    Intervention Type
    Biological
    Intervention Name(s)
    Candida antigen
    Intervention Description
    Intralesional injection of Candidal antigen with a dose of (0.1ml -0.3ml) by an insulin syringe in the largest wart at the first visit. Injections will be repeated for all patients into the same lesion every 2 weeks for a maximum of three treatment sessions.
    Intervention Type
    Drug
    Intervention Name(s)
    Topical Podophyllin
    Intervention Description
    It will be applied to the wart by using a cotton tipped swab once a week . The procedure will be limited to 10 cm2 per session .Surrounding skin will be protected by Vaseline. Podophyllin will be washed 4 hour after application . The procedure will be repeated every week till 6 weeks .
    Primary Outcome Measure Information:
    Title
    Cure rate
    Description
    Assess cure rate of MMR vaccine and candida antigen and topical podophyllin in treatment of genital warts (complete disappearance of lesions) in 45 days duration and compare efficacy of the measures.
    Time Frame
    45 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with anogenital warts with ages ranging from 3 to 50 years Genital warts resistant to treatment Genital warts that had relapsed at least once after treatment with any of the tissue-destructive modalities. Exclusion Criteria: Patients with any evidence of immunosuppression Eczematous skin disorder Those with any history of hypersensitivity to Candida albicans antigen Pregnant or lactating women.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hisham Zayan, MD
    Phone
    201223971409
    Ext
    00+20
    Email
    hishamzayan@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yasmin tawfik, MD
    Phone
    201006033331
    Ext
    00+20
    Email
    dr.yasminmostawfik@yahoo.com

    12. IPD Sharing Statement

    Learn more about this trial

    Efficacy of Intralesional MMR Vaccine,Intralesional Candidal Antigen&Topical Podophyllin in Treatment of Genital Warts

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