Intralesional Treatment of Plantar Wart

NCT05057663 | Unknown

• 1 other identifier: Soh-Med-21-09-03
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Plantar Wart

Keywords

Intralesional Injection.; Bleomycin.; 5-Fluorouracil.

Outcome Measures

Primary Outcomes (1)

• 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 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

Study Arms (2)

Bleomycin group

ACTIVE COMPARATOR

Drug: Bleomycin and 5-fluorouracil

5-Fluorouracil group

ACTIVE COMPARATOR

Drug: Bleomycin and 5-fluorouracil

Interventions

Bleomycin and 5-fluorouracil DRUG

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

5-Fluorouracil group; Bleomycin group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag Faculty of Medicine

Sohag, Egypt

Location

MeSH Terms

Interventions

Bleomycin; Fluorouracil

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Rania Farouk, Resident

  Sohag Faculty of medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rania Farouk, Resident

CONTACT

01283074271; rania_farouk_post@med.sohag.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Dermatology, Andrology and Venerology, Principal investigator, clinical professor

Study Record Dates

• First Submitted: September 12, 2021
• First Posted: September 27, 2021
• Study Start: November 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: September 1, 2022
• Last Updated: September 28, 2021

Record last verified: 2021-09

Locations

EG (1)