Intralesional Treatment of Plantar Wart
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 |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Active Comparator: Bleomycin group
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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
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Active Comparator: 5-Fluorouracil group
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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
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Outcome Measures
Primary Outcome Measures
- 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
Inclusion Criteria:
Subjects must meet all of the following criteria to be considered for participation in this study.
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Subject is able to comprehend and is willing to sign an informed consent/assent for participation in this study.
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Male or female ≥ 8 years old.
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Subject has a clinical diagnosis of common warts.
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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:
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Each wart must have a longest axis that is ≥ 3mm and ≤ 8 mm and have a thickness of ≤3mm
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Each wart must be a discrete lesion
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Each wart must be present for at least 4 weeks
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Not be covered with hair which, in the investigator's opinion, would interfere with the study medication treatment or the study evaluations
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Not be in an intertriginous fold
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Be the only common wart present when the circular cutout template is centered over the wart
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The Target and Non-Target Warts must have a PWA ≥ 2.
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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.
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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.
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Subject is non-pregnant and non-lactating.
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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.
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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:
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Subject has clinically atypical warts on the trunk or extremities.
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Subject is immunocompromised (e.g., due to chemotherapy, systemic steroids, genetic immunodeficiency, transplant
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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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.- Soh-Med-21-09-03