Intralesional Treatment of Plantar Wart

NCT ID: NCT05057663

Last Updated: 2021-09-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2022-09-01

Brief Summary

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

Conditions

Plantar Wart

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bleomycin group

Group Type: ACTIVE_COMPARATOR

Bleomycin and 5-fluorouracil

Intervention Type: 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

Group Type: ACTIVE_COMPARATOR

Bleomycin and 5-fluorouracil

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Rania Farouk Daif

Director, Head of Dermatology, Andrology and Venerology, Principal investigator, clinical professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rania Farouk, Resident

Role: PRINCIPAL_INVESTIGATOR

Sohag Faculty of medicine

Locations

Sohag Faculty of Medicine

Sohag, , Egypt

Countries

Egypt

Central Contacts

Rania Farouk, Resident

Role: CONTACT

rania_farouk_post@med.sohag.edu.eg

01283074271

Facility Contacts

Rania Farouk, resident

Role: primary

rania_farouk_post@med.sohag.edu.eg

01283074271

Other Identifiers

Soh-Med-21-09-03

Identifier Type: -

Identifier Source: org_study_id