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The Efficacy of Intra-lesional Bleomycin Versus Intra-lesional Purified Protein Derivative in Treatment of Palmoplantar Warts

Primary Purpose

Warts

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Bleomycin
Purified Protein Derivative
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Warts

Eligibility Criteria

15 Years - 40 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients with positive tuberculin test or with past history of PPD vaccination will include.
  • Patient with normal CBC , liver function and renal function

Exclusion Criteria:

  • Patients with immunosuppression, pregnancy, or lactation, with negative tuberculin test or with past history of tuberculosis, peripheral vascular disease, any abnormality in liver or renal function and those who received any wart treatment 1 month before the start of the study will exclude.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    PPD group

    Bleomycin group

    Arm Description

    This group will include 20 patients who will be treated with IL injection of PPD at a dose of 10 IU (0.1 ml) supplied an insulin syringe in the largest wart. Injections will be repeated for all patients into the same lesion (largest wart) every 2 weeks for three treatment sessions

    This group will include 20 patients who will be treated with IL injection of bleomycin. Injections will be repeated for all patients into the same lesion (largest wart) every 2 weeks for three treatment sessions, if needed.

    Outcomes

    Primary Outcome Measures

    The cure rate of patients
    the clinical disappearance of the warts

    Secondary Outcome Measures

    Full Information

    First Posted
    March 12, 2018
    Last Updated
    March 23, 2018
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03477448
    Brief Title
    The Efficacy of Intra-lesional Bleomycin Versus Intra-lesional Purified Protein Derivative in Treatment of Palmoplantar Warts
    Official Title
    The Efficacy of Intra-lesional Bleomycin Versus Intra-lesional Purified Protein Derivative in Treatment of Palmoplantar Warts
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 1, 2018 (Anticipated)
    Primary Completion Date
    April 1, 2019 (Anticipated)
    Study Completion Date
    April 1, 2020 (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
    Warts are common viral infections on the skin and are prevalent worldwide. Warts are caused by the human Papilloma virus (HPV), which has more than 100 strains; some of them are known to be premalignant. Although warts can appear at any age, they are more common in children and adolescents. The prognosis of warts cannot be predicted. In some patients they may spontaneously disappear, whereas others show persistence and progression with spreading to other body sites, leading to physical and emotional distress to the patients. Factors that increase the risk include use of public showers, working with meat, eczema, and a low immune system . The virus is believed to enter the body through skin that has been damaged slightly . A number of types exist including: common warts, plantar warts, filiform warts, and genital warts . Genital warts are often sexually transmitted.
    Detailed Description
    Selection of the most appropriate means of treatment is usually difficult because of the availability of various therapeutic lines and also due to the variability in the immune status of the patients for treatment of warts. There are on two main therapeutic options: the first is the conventional destructive and aggressive method, which includes treatment with chemical cautery, cryo- therapy, electro cauterization, surgical excision, and laser ablation . This method depends on destruction of the area of epidermis infected with the virus. The recurrence rates after these therapy modalities maybe high. The second is the immunotherapy, which is based on the activation of the immune system to deal with the virus and suppress its activity. Such therapy may be applied either topically or through intra- lesional injection or through systemic administration . Intra-lesional immunotherapy utilizes the ability of the immune system to mount a delayed-type hypersensitivity response to various antigens and also the wart tissue. This therapy has been found to be associated with the production of Th1 cytokines that activate cytotoxic and natural killer cells to eradicate HPV infection. This clears not only the local warts but also distant warts, unlike traditional wart therapies . Many authors have used different immunotherapeutic agents for intralesional injection. These include Candida antigen, mumps antigen, trichophytin skin test antigen, BCG vaccine, measles, mumps, and rubella (MMR) vaccine, Mycobacterium w (Mw) vaccine, and IFN-α and IFN-γ injectio). Bleomycin, an antibiotic derived from Streptomyces verticillus, has an antitumor, antibacterial, and antiviral activity that may be related to its ability to bind with DNA, causing bleomycin strand scission and elimination of pyrimidine and purine bases. The bleomycin hydrolase enzyme, which is known to inactivate bleomycin, is normally found in all body tissues but is present in very small amounts in skin. Intra-lesional bleomycin injection (IBI) has been used for the treatment of warts. Numerous reports have been published on the use of intra-lesional bleomycin for the treatment of recalcitrant warts with cure rates ranging from 14 to 99%. It was found to be very effective in treating warts particularly in periungual and palmoplantar areas . No systemic side effects have been observed. However, local signs such as necrosis, pain, scaring, pigment change, Raynaud's phenomenon, and nail dystrophy may occur in some cases. Purified protein derivative (PPD) is an extract of Mycobacterium tuberculosis and is used for testing exposure to tuberculin protein, either from a previous vaccination or from the environment. It contains live, attenuated Mycobacterium bovis. Using this protein derivative for immunotherapy of warts is important for two major aspects. First, because the obligatory immunization program in many developing countries - with high prevalence of wart in many of them - includes BCG vaccination. PPD has a high prevalence of immunity in the general population. Second, although immunotherapy is generally an inexpensive method of treatment in wart patients, PPD, among conventionally used antigens, is the cheapest. IL purified protein derivative (PPD) injection is an acceptable and safe modality in the treatment of warts with complete response in 75% of patients.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    PPD group
    Arm Type
    Active Comparator
    Arm Description
    This group will include 20 patients who will be treated with IL injection of PPD at a dose of 10 IU (0.1 ml) supplied an insulin syringe in the largest wart. Injections will be repeated for all patients into the same lesion (largest wart) every 2 weeks for three treatment sessions
    Arm Title
    Bleomycin group
    Arm Type
    Active Comparator
    Arm Description
    This group will include 20 patients who will be treated with IL injection of bleomycin. Injections will be repeated for all patients into the same lesion (largest wart) every 2 weeks for three treatment sessions, if needed.
    Intervention Type
    Drug
    Intervention Name(s)
    Bleomycin
    Intervention Description
    an antibiotic derived from Streptomyces verticillus, has an antitumor, antibacterial, and antiviral activity that may be related to its ability to bind with DNA, causing bleomycin strand scission and elimination of pyrimidine and purine bases. The bleomycin hydrolase enzyme, which is known to inactivate bleomycin, is normally found in all body tissues but is present in very small amounts in skin . Intra-lesional bleomycin injection (IBI) has been used for the treatment of warts.
    Intervention Type
    Drug
    Intervention Name(s)
    Purified Protein Derivative
    Intervention Description
    is an extract of Mycobacterium tuberculosis and is used for testing exposure to tuberculin protein, either from a previous vaccination or from the environment. It contains live, attenuated Mycobacterium bovis. Using this protein derivative for immunotherapy of warts is important for two major aspects. First, because the obligatory immunization program in many developing countries - with high prevalence of wart in many of them - includes BCG vaccination. PPD has a high prevalence of immunity in the general population. Second, although immunotherapy is generally an inexpensive method of treatment in wart patients, PPD, among conventionally used antigens, is the cheapest
    Primary Outcome Measure Information:
    Title
    The cure rate of patients
    Description
    the clinical disappearance of the warts
    Time Frame
    One year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients with positive tuberculin test or with past history of PPD vaccination will include. Patient with normal CBC , liver function and renal function Exclusion Criteria: Patients with immunosuppression, pregnancy, or lactation, with negative tuberculin test or with past history of tuberculosis, peripheral vascular disease, any abnormality in liver or renal function and those who received any wart treatment 1 month before the start of the study will exclude.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    24865780
    Citation
    Lynch MD, Cliffe J, Morris-Jones R. Management of cutaneous viral warts. BMJ. 2014 May 27;348:g3339. doi: 10.1136/bmj.g3339. No abstract available.
    Results Reference
    background
    PubMed Identifier
    17034512
    Citation
    Yamamoto T. Bleomycin and the skin. Br J Dermatol. 2006 Nov;155(5):869-75. doi: 10.1111/j.1365-2133.2006.07474.x.
    Results Reference
    background

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    The Efficacy of Intra-lesional Bleomycin Versus Intra-lesional Purified Protein Derivative in Treatment of Palmoplantar Warts

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