Intralesional Treatment of Plantar Wart

September 26, 2021 updated by: Rania Farouk Daif, Sohag University

Intralesional Injection of Bleomycin Versus 5-fluorouracil in Treatment of Plantar Wart; a Comparative Study

Group 1; intralesional injection of bleomycin in plantar wart. Group 2; intralesional injection of 5-fluorouracil in plantar wart

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Bleomycin group
Drug: Bleomycin and 5-fluorouracil

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
Active Comparator: 5-Fluorouracil group
Drug: Bleomycin and 5-fluorouracil

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response to intralesional injection of bleomycin, 5fluorouracil in treatment of plantar wart
Time Frame: 3monthes

Physician's Wart Assessment Grade Descriptor 0 Clear: No visible wart. No further treatment is indicated

  1. Near Clear: A visible wart that is less than 3mm in maximal diameter (or length)
  2. A visible wart ≥ 3mm and <6 mm in maximal diameter (or length)
  3. A visible wart ≥ 6mm in maximal diameter (or length)
3monthes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Investigators

  • Principal Investigator: Rania Farouk, Resident, Sohag Faculty of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2021

Primary Completion (Anticipated)

March 1, 2022

Study Completion (Anticipated)

September 1, 2022

Study Registration Dates

First Submitted

September 12, 2021

First Submitted That Met QC Criteria

September 15, 2021

First Posted (Actual)

September 27, 2021

Study Record Updates

Last Update Posted (Actual)

September 28, 2021

Last Update Submitted That Met QC Criteria

September 26, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-21-09-03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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