Intralesional Treatment of Plantar Wart

Sponsor
Sohag University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05057663
Collaborator
(none)
40
1
2
10
4

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Bleomycin and 5-fluorouracil
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Intralesional Injection of Bleomycin Versus 5-fluorouracil in Treatment of Plantar Wart; a Comparative Study
Anticipated Study Start Date :
Nov 1, 2021
Anticipated Primary Completion Date :
Mar 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Response to intralesional injection of bleomycin, 5fluorouracil in treatment of plantar wart [3monthes]

    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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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:

  5. Each wart must have a longest axis that is ≥ 3mm and ≤ 8 mm and have a thickness of ≤3mm

  6. Each wart must be a discrete lesion

  7. Each wart must be present for at least 4 weeks

  8. Not be covered with hair which, in the investigator's opinion, would interfere with the study medication treatment or the study evaluations

  9. Not be in an intertriginous fold

  10. Be the only common wart present when the circular cutout template is centered over the wart

  11. The Target and Non-Target Warts must have a PWA ≥ 2.

  12. 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.

  13. 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.

  14. Subject is non-pregnant and non-lactating.

  15. 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.

  16. 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sohag Faculty of Medicine Sohag Egypt

Sponsors and Collaborators

  • Sohag University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rania Farouk Daif, Director, Head of Dermatology, Andrology and Venerology, Principal investigator, clinical professor, Sohag University
ClinicalTrials.gov Identifier:
NCT05057663
Other Study ID Numbers:
  • Soh-Med-21-09-03
First Posted:
Sep 27, 2021
Last Update Posted:
Sep 28, 2021
Last Verified:
Sep 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Rania Farouk Daif, Director, Head of Dermatology, Andrology and Venerology, Principal investigator, clinical professor, Sohag University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 28, 2021