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Intralesional Treatment of Plantar Wart

Primary Purpose

Plantar Wart

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Bleomycin and 5-fluorouracil
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plantar Wart focused on measuring Intralesional Injection., Bleomycin., 5-Fluorouracil.

Eligibility Criteria

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

Inclusion Criteria:

Subjects must meet all of the following criteria to be considered for participation in this study.

  1. Subject is able to comprehend and is willing to sign an informed consent/assent for participation in this study.
  2. Male or female ≥ 8 years old.
  3. Subject has a clinical diagnosis of common warts.

  4. Subject has up to 1 Target Wart and up to 3 additional Non-Target Warts located on the trunk or extremities. The identified Target and Non-Target Warts must meet the requirements as defined below:

    1. Each wart must have a longest axis that is ≥ 3mm and ≤ 8 mm and have a thickness of ≤3mm
    2. Each wart must be a discrete lesion
    3. Each wart must be present for at least 4 weeks
    4. Not be covered with hair which, in the investigator's opinion, would interfere with the study medication treatment or the study evaluations
    5. Not be in an intertriginous fold
    6. Be the only common wart present when the circular cutout template is centered over the wart
  5. The Target and Non-Target Warts must have a PWA ≥ 2.
  6. Subject chemistry and complete blood count results are within normal limits. If any of the laboratory values are outside normal range, the treating investigator must assess the value/s as NOT clinically significant and document this in the subject's medical chart in order for the subject to be eligible for randomization.
  7. Woman of childbearing potential (WOCBP) must have a negative urine pregnancy test within 14 days of the first application of study drug and agree to use an active method of birth control for the duration of the study.
  8. Subject is non-pregnant and non-lactating.
  9. Subject is in good general health and free of any known disease state or physical condition which, in the investigator's opinion, might impair the evaluation of any Target or Non-Target Warts or which exposes the subject to an unacceptable risk by study participation.
  10. Subject is willing and able to follow all study instructions and to attend all study visits.

Exclusion Criteria:

Subjects are excluded from this study if any 1 or more of the following criteria is met:

  1. Subject has clinically atypical warts on the trunk or extremities.
  2. Subject is immunocompromised (e.g., due to chemotherapy, systemic steroids, genetic immunodeficiency, transplant

Sites / Locations

  • Sohag Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Bleomycin group

5-Fluorouracil group

Arm Description

Outcomes

Primary Outcome Measures

Response to intralesional injection of bleomycin, 5fluorouracil in treatment of plantar wart
Physician's Wart Assessment Grade Descriptor 0 Clear: No visible wart. No further treatment is indicated Near Clear: A visible wart that is less than 3mm in maximal diameter (or length) A visible wart ≥ 3mm and <6 mm in maximal diameter (or length) A visible wart ≥ 6mm in maximal diameter (or length)

Secondary Outcome Measures

Full Information

First Posted
September 12, 2021
Last Updated
September 26, 2021
Sponsor
Sohag University
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1. Study Identification

Unique Protocol Identification Number
NCT05057663
Brief Title
Intralesional Treatment of Plantar Wart
Official Title
Intralesional Injection of Bleomycin Versus 5-fluorouracil in Treatment of Plantar Wart; a Comparative Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2021 (Anticipated)
Primary Completion Date
March 1, 2022 (Anticipated)
Study Completion Date
September 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag 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
Group 1; intralesional injection of bleomycin in plantar wart. Group 2; intralesional injection of 5-fluorouracil in plantar wart

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plantar Wart
Keywords
Intralesional Injection., Bleomycin., 5-Fluorouracil.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bleomycin group
Arm Type
Active Comparator
Arm Title
5-Fluorouracil group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Bleomycin and 5-fluorouracil
Intervention Description
In the bleomycin-treated group, bleomycin vial will be diluted first with 5 ml distilled water At time of treatment session 2 ml of lidocaine 2% and 1 ml of the bleomycin stock solution will be taken in 100-unite insulin syringe. Thus, the working bleomycin solution will be used in treatment 1 mg/ml. The bleomycin solution will be injected intralesional till blanching of the wart will be occurred. The amount of injection ranging from 0.2, 0.5, 1 ml according to size of warts; (5 mm, 10 mm, >10 mm) maximum for 1 ml in single wart and 2ml in treatment session. Treatment session will be done every two weeks maximum four sessions. In 5-fluorouracil treated group, 5-fluorouracil vial ( 1 ml of 50 mg/ml 5-FU will be mixed with 0.25 ml of lidcaine 2% Every wart will be injected with 0.1 ml of the previous mixture into it base using an insulin syringe till blanching of the warts maximum 2ml of 5-FU per session. Treatment session will be done every two week for maximum 6 sessions
Primary Outcome Measure Information:
Title
Response to intralesional injection of bleomycin, 5fluorouracil in treatment of plantar wart
Description
Physician's Wart Assessment Grade Descriptor 0 Clear: No visible wart. No further treatment is indicated Near Clear: A visible wart that is less than 3mm in maximal diameter (or length) A visible wart ≥ 3mm and <6 mm in maximal diameter (or length) A visible wart ≥ 6mm in maximal diameter (or length)
Time Frame
3monthes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects must meet all of the following criteria to be considered for participation in this study. Subject is able to comprehend and is willing to sign an informed consent/assent for participation in this study. Male or female ≥ 8 years old. Subject has a clinical diagnosis of common warts. Subject has up to 1 Target Wart and up to 3 additional Non-Target Warts located on the trunk or extremities. The identified Target and Non-Target Warts must meet the requirements as defined below: Each wart must have a longest axis that is ≥ 3mm and ≤ 8 mm and have a thickness of ≤3mm Each wart must be a discrete lesion Each wart must be present for at least 4 weeks Not be covered with hair which, in the investigator's opinion, would interfere with the study medication treatment or the study evaluations Not be in an intertriginous fold Be the only common wart present when the circular cutout template is centered over the wart The Target and Non-Target Warts must have a PWA ≥ 2. Subject chemistry and complete blood count results are within normal limits. If any of the laboratory values are outside normal range, the treating investigator must assess the value/s as NOT clinically significant and document this in the subject's medical chart in order for the subject to be eligible for randomization. Woman of childbearing potential (WOCBP) must have a negative urine pregnancy test within 14 days of the first application of study drug and agree to use an active method of birth control for the duration of the study. Subject is non-pregnant and non-lactating. Subject is in good general health and free of any known disease state or physical condition which, in the investigator's opinion, might impair the evaluation of any Target or Non-Target Warts or which exposes the subject to an unacceptable risk by study participation. Subject is willing and able to follow all study instructions and to attend all study visits. Exclusion Criteria: Subjects are excluded from this study if any 1 or more of the following criteria is met: Subject has clinically atypical warts on the trunk or extremities. Subject is immunocompromised (e.g., due to chemotherapy, systemic steroids, genetic immunodeficiency, transplant
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rania Farouk, Resident
Phone
01283074271
Email
rania_farouk_post@med.sohag.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rania Farouk, Resident
Organizational Affiliation
Sohag Faculty of medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sohag Faculty of Medicine
City
Sohag
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rania Farouk, resident
Phone
01283074271
Email
rania_farouk_post@med.sohag.edu.eg

12. IPD Sharing Statement

Learn more about this trial

Intralesional Treatment of Plantar Wart

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