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Efficacy of Cryotherapy Combined With Intralesional Tuberculin PPD Versus Intralesional Tuberculin PPD in Treatment of Multiple Common Warts

Primary Purpose

Common Wart

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Tuberculin purified protein derivative
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Common Wart focused on measuring wart, Intralesional tuberculin PPD

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. A dults older than 18 years
  2. multiple (>3 warts) common warts .
  3. not currently using other treatments for a wart .
  4. not had relapsed at least once after treatment with any of the tissue-destructive modalities.
  5. Positive tuberculin skin test.

Exclusion Criteria:

  • Acute febrile illness, history of asthma, allergic skin disorders.-1 2- Pregnancy or lactation. 3- Cold-induced diseases. 4- Immunosuppression.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Cryotherapy and intralesional tuberculin PPD

    Intralesional tuberculin PPD

    Arm Description

    Efficacy of cryotherapy combined with intralesional tuberculin purified protein in treatment of multiple common warts

    Efficacy of Intralesional tuberculin purified protein deravative monotherapy in the treatment of multiple common warts

    Outcomes

    Primary Outcome Measures

    Size of lesions
    By decreasing in size after treatment and compare the response of the lesions tow treatment lines
    Number of lesions
    The following grading system will be used to evaluate treatment response: *Complete response: responders who show 100% improvement (disappearance of all warts and return to normal skin markings). Marked response: responders who show 76 to 99% decrease in number and/or decrease in apparent size, as assessed by a clinician and photographic evaluation also known as near-complete response. Moderate response: partial responders show 25 to 75% improvement. No or minimal response: less than 25% decrease in size/numbers of all warts. the study

    Secondary Outcome Measures

    Full Information

    First Posted
    February 19, 2020
    Last Updated
    February 26, 2020
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04288817
    Brief Title
    Efficacy of Cryotherapy Combined With Intralesional Tuberculin PPD Versus Intralesional Tuberculin PPD in Treatment of Multiple Common Warts
    Official Title
    Efficacy of Cryotherapy Combined With Intralesional Tuberculin Purified Protein Derivative (PPD) Versus Interlesional Tuberculin PPD Monotherapy in the Treatment of Multiple Common Warts
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 1, 2020 (Anticipated)
    Primary Completion Date
    March 1, 2021 (Anticipated)
    Study Completion Date
    May 1, 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
    The investigate the efficacy and safety of combined 'cryo-immuno-therapy' versus intralesional tuberculin purified protein derivative (PPD) antigen immunotherapy alone for multiple common warts
    Detailed Description
    Common warts are benign skin lesions caused by the human papillomavirus (HPV). The dorsal surface of the hands and fingers are the main predilection sites. Cryotherapy is frequently used to eradicate common warts via necrotic destruction of HPV-infected keratinocytes or by inducing of an effective cell-mediated immune response. However, the cure rates of cryotherapy are only around (44-47%) . Intralesional antigen immunotherapy represents a promising therapeutic approach for the treatment of different types of warts, particularly if multiple and/or recalcitrant. The investigate the efficacy and safety of combined 'cryo-immuno-therapy' versus intralesional tuberculin purified protein n immunotherapy alone for multiple common warts. Although intralesional immunotherapy - compared to conventional therapeutic methods - has been generally along with better outcome, lower incidence of side effects and less recurrence, it is not still approved as a standard method of treatment in patients with wart , because the majority of available studies are open-labeled and randomized, placebo-controlled trials are very scarce. The immune system plays an important role in the spontaneous resolution of warts. The immune mechanisms against HPV include the development of cell-mediated immune response with activation of T helper1 (Th1) lymphocytes resulting in long-term immunity . Stimulation of the immune system would clear warts in other locations, eliminating the need for the local treatment for each individual wart . Multiple studies support the use of intralesional PPD injection as an effective and valuable treatment option due to its systemic effect, especially for patients with multiple warts, with the benefit of clearance of both treated and distant warts.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Common Wart
    Keywords
    wart, Intralesional tuberculin PPD

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Cryotherapy and intralesional tuberculin PPD
    Arm Type
    Active Comparator
    Arm Description
    Efficacy of cryotherapy combined with intralesional tuberculin purified protein in treatment of multiple common warts
    Arm Title
    Intralesional tuberculin PPD
    Arm Type
    Active Comparator
    Arm Description
    Efficacy of Intralesional tuberculin purified protein deravative monotherapy in the treatment of multiple common warts
    Intervention Type
    Biological
    Intervention Name(s)
    Tuberculin purified protein derivative
    Intervention Description
    Intralesional injection of tuberculin PPD in treatment of multiple common warts
    Primary Outcome Measure Information:
    Title
    Size of lesions
    Description
    By decreasing in size after treatment and compare the response of the lesions tow treatment lines
    Time Frame
    Two months
    Title
    Number of lesions
    Description
    The following grading system will be used to evaluate treatment response: *Complete response: responders who show 100% improvement (disappearance of all warts and return to normal skin markings). Marked response: responders who show 76 to 99% decrease in number and/or decrease in apparent size, as assessed by a clinician and photographic evaluation also known as near-complete response. Moderate response: partial responders show 25 to 75% improvement. No or minimal response: less than 25% decrease in size/numbers of all warts. the study
    Time Frame
    4 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: A dults older than 18 years multiple (>3 warts) common warts . not currently using other treatments for a wart . not had relapsed at least once after treatment with any of the tissue-destructive modalities. Positive tuberculin skin test. Exclusion Criteria: Acute febrile illness, history of asthma, allergic skin disorders.-1 2- Pregnancy or lactation. 3- Cold-induced diseases. 4- Immunosuppression.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hiba Abdullah
    Phone
    01021432461
    Ext
    0020
    Email
    hibaalshaaby7@yahoo.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Efficacy of Cryotherapy Combined With Intralesional Tuberculin PPD Versus Intralesional Tuberculin PPD in Treatment of Multiple Common Warts

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