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Comparison Between Tuberculin Vaccine and Cryotherapy in Genital Wart Patients

Primary Purpose

Genital Wart

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
tuberculin
cryotherapy
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Genital Wart

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All types of genital and anal warts will be included in this study especially patients with 5 or more warts and more than 1 cm in size

Exclusion Criteria:

  • Patients with immunodeficient diseases or receiving any immunosuppressive drugs
  • Pregnancy and lactation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Experimental

    Arm Label

    study group

    control group

    combined group

    Arm Description

    include (15) patients will be injected with Tuberculin vaccine 0.3 ml every 2 weeks, vaccine will be injected in the largest wart, 4 sessions will be done then patients will be followed for 2 months

    include (15) patients will be treated with cryotherapy every 2 weeks ,4 sessions will be done then patients will be followed for 2 months

    include (15) patients will be treated with combined cryotherapy and Tuberculin vaccine , one week cryotherapy and the other week Tuberculin vaccine , then patients will be followed for 2 weeks

    Outcomes

    Primary Outcome Measures

    number of patients with complete resolution of genital warts
    frequency (number)

    Secondary Outcome Measures

    Full Information

    First Posted
    May 12, 2017
    Last Updated
    May 15, 2017
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03153566
    Brief Title
    Comparison Between Tuberculin Vaccine and Cryotherapy in Genital Wart Patients
    Official Title
    Comparison Between Tuberculin Vaccine and Cryotherapy in the Treatment of Genital Wart Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 1, 2017 (Anticipated)
    Primary Completion Date
    June 2018 (Anticipated)
    Study Completion Date
    December 2018 (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
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Cutaneous and genital warts are common dermatological conditions caused by Human Papilloma Virus. Although it is a benign condition it causes disfigurement, has tendency to collect, can be transmitted to others, this makes adequate and timely treatment important, while many warts are resolve spontaneously over several years, most patients seek treatment because the warts are unsightly and often tender or painful.
    Detailed Description
    Genital warts are highly contagious sexually transmitted diseases (STD) caused by infection of Human Papilloma Virus and, as the most common STD in developed countries, can currently be considered to be globally epidemic. It is estimated that the frequency of Human Papilloma Virus infection among women in the world ranges from 2% to 44%. The conventional modalities in treatment of warts include destructive therapies such as salicylic acid, trichloroacetic acid, cryotherapy, silver nitrate, phenol, cantharidin, surgical interventions and laser, antiproliferative agents such as bleomycin, vitamin D analogs, podophyllin, 5 fluorouracil and antiviral agents such as cidofovir and retinoids. There are different mechanisms have been proposed for the resolution of warts with skin test antigens such as mumps, candida, trichophyton both at the injected as well as distant sites. Tuberculin: Purified protein derivative or tuberculin stimulates the cell mediated immunity non specifically by activating T helper 1 cells, Natural Killer cells, and cytokine production an increase in interleukin-12 as a process in boosting the cell-mediated immunity contributes to the mechanism of action.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Genital Wart

    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
    study group
    Arm Type
    Experimental
    Arm Description
    include (15) patients will be injected with Tuberculin vaccine 0.3 ml every 2 weeks, vaccine will be injected in the largest wart, 4 sessions will be done then patients will be followed for 2 months
    Arm Title
    control group
    Arm Type
    Active Comparator
    Arm Description
    include (15) patients will be treated with cryotherapy every 2 weeks ,4 sessions will be done then patients will be followed for 2 months
    Arm Title
    combined group
    Arm Type
    Experimental
    Arm Description
    include (15) patients will be treated with combined cryotherapy and Tuberculin vaccine , one week cryotherapy and the other week Tuberculin vaccine , then patients will be followed for 2 weeks
    Intervention Type
    Biological
    Intervention Name(s)
    tuberculin
    Intervention Description
    inject the mother wart with .3 ml tuberculin vaccine every 2 weeks
    Intervention Type
    Device
    Intervention Name(s)
    cryotherapy
    Intervention Description
    10 sec 1 cycle into all genital warts
    Primary Outcome Measure Information:
    Title
    number of patients with complete resolution of genital warts
    Description
    frequency (number)
    Time Frame
    4 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: All types of genital and anal warts will be included in this study especially patients with 5 or more warts and more than 1 cm in size Exclusion Criteria: Patients with immunodeficient diseases or receiving any immunosuppressive drugs Pregnancy and lactation

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    11238198
    Citation
    Scott M, Nakagawa M, Moscicki AB. Cell-mediated immune response to human papillomavirus infection. Clin Diagn Lab Immunol. 2001 Mar;8(2):209-20. doi: 10.1128/CDLI.8.2.209-220.2001. No abstract available.
    Results Reference
    result
    PubMed Identifier
    16973081
    Citation
    Buck HW Jr. Genital warts. Clin Evid. 2006 Jun;(15):2149-61. No abstract available.
    Results Reference
    result
    PubMed Identifier
    12807939
    Citation
    Bosch FX, de Sanjose S. Chapter 1: Human papillomavirus and cervical cancer--burden and assessment of causality. J Natl Cancer Inst Monogr. 2003;(31):3-13. doi: 10.1093/oxfordjournals.jncimonographs.a003479.
    Results Reference
    result
    PubMed Identifier
    25273231
    Citation
    Sterling JC, Gibbs S, Haque Hussain SS, Mohd Mustapa MF, Handfield-Jones SE. British Association of Dermatologists' guidelines for the management of cutaneous warts 2014. Br J Dermatol. 2014 Oct;171(4):696-712. doi: 10.1111/bjd.13310. Epub 2014 Oct 1. No abstract available.
    Results Reference
    result
    PubMed Identifier
    15897380
    Citation
    Horn TD, Johnson SM, Helm RM, Roberson PK. Intralesional immunotherapy of warts with mumps, Candida, and Trichophyton skin test antigens: a single-blinded, randomized, and controlled trial. Arch Dermatol. 2005 May;141(5):589-94. doi: 10.1001/archderm.141.5.589.
    Results Reference
    result
    PubMed Identifier
    23336207
    Citation
    Abd-Elazeim FM, Mohammed GF, Fathy A, Mohamed RW. Evaluation of IL-12 serum level in patients with recalcitrant multiple common warts, treated by intralesional tuberculin antigen. J Dermatolog Treat. 2014 Jun;25(3):264-7. doi: 10.3109/09546634.2013.768760. Epub 2013 May 6.
    Results Reference
    result

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    Comparison Between Tuberculin Vaccine and Cryotherapy in Genital Wart Patients

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