Intralesional Treatment of Plantar Wart

Sohag University

Status: Unknown

Conditions: Plantar Wart

Treatments: Drug: Bleomycin and 5-fluorouracil

Study type: Interventional

Funder types: Other

Identifiers

NCT05057663

Soh-Med-21-09-03

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

Bleomycin group

Active Comparator group

Treatment:

Drug: Bleomycin and 5-fluorouracil

5-Fluorouracil group

Active Comparator group

Treatment:

Drug: Bleomycin and 5-fluorouracil