Intralesional Injection of Combined Digoxin and Furosemide Versus 5-Flurouracil in Plantar Warts
The Efficacy of Intralesional Injection of Combined Digoxin and Furosemide Versus 5-Flurouracil in the Treatment of Plantar Warts
1 other identifier
interventional
45
0 countries
N/A
Brief Summary
The aim of the current work is to evaluate the efficacy and safety of intralesional combined Digoxin and furosemide versus intralesional 5-flurouracil in the treatment of plantar warts.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2023
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 19, 2022
CompletedFirst Posted
Study publicly available on registry
October 31, 2022
CompletedStudy Start
First participant enrolled
February 22, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2024
CompletedFebruary 21, 2023
February 1, 2023
8 months
October 19, 2022
February 17, 2023
Conditions
Outcome Measures
Primary Outcomes (4)
change in size of the warts
The studied warts will be clinically evaluated regarding change in size
through study completion, an average of 9 months
Dermoscopic evaluation
The patients will be categorized in to 4 scores according to their response to treatment as: Score 0: patients showed neither clinical response nor dermoscopic clearance of warts 2 weeks after the last treatment session. Score 1: patients showed clinical improvement with decreased size of wart and thickness of callus without dermoscopic clearance of warts 2 weeks after the last treatment session. Score 2: patients showed disappearance of warts clinically (clinical clearance) but dermoscopic examination revealed remnants of warts 2 weeks after the last treatment session. Score 3: patients showed clinical and dermoscopic clearance of warts 2 weeks after the last treatment session (Barkat et al., 2018).
through study completion, an average of 9 months
treatment-related adverse effects
Immediate and late adverse effects will be evaluated
through study completion, an average of 9 months
Patients' satisfaction
Patients' satisfaction will be evaluated through a questionnaire. Patients' satisfaction will be graded into (very satisfied, satisfied, and unsatisfied).
through study completion, an average of 9 months
Study Arms (3)
Group A
ACTIVE COMPARATOR15 patients will receive intralesional 0.1 mL of combined digoxin and furosemide, with maximum 5 warts per session.
Group B
ACTIVE COMPARATOR15 patients will receive intralesional injection of 5- Fluorouracil (50mg/ml) in full concentration into the wart using a 27- gauge insulin syringe till the entire lesion begins to puff up. The maximum dose injected per session will be 2ml of 5-FU.
Group c
PLACEBO COMPARATOR15 patients will receive intralesional saline.
Interventions
15 patients will receive intralesional combined digoxin and furosemide, with maximum 5 warts per session. 0.2 mL of lignocaine (20 mg/mL) will be used as a local analgesic and after few minutes, 0.1 mL of combined digoxin and furosemide solution will be slowly injected into the base of each wart. Selected patients will receive one session every 2 weeks till complete clearance or up to 5 sessions.
15 patients will receive intralesional injection of 5- Fluorouracil (50mg/ml) in full concentration into the wart using a 27- gauge insulin syringe till the entire lesion begins to puff up. The maximum dose injected per session will be 2ml of 5-FU. Selected patients will receive one session every 2 weeks till complete clearance or up to 5 sessions.
15 patients will receive intralesional saline. Selected patients will receive one session every 2 weeks till complete clearance or up to 5 sessions.
Eligibility Criteria
You may qualify if:
- Patients with multiple plantar warts (≥ 3) will be included.
You may not qualify if:
- Patients under 18 years old or patients over 65 years old.
- Pregnancy or breast feeding.
- Patients received vaccination or any other treatment of warts during the last month.
- Patients with a known sensitivity to any of the investigational product ingredients.
- Patients with history of asthma, allergic skin disorders or convulsions.
- Patients with signs of any systemic or local inflammation or infection.
- Patients with any evidence of immunosuppression including HIV.
- History of cardiac diseases, relevant abnormal K level or ECG abnormalities for patients who will receive the combined digoxin and furosemide.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 19, 2022
First Posted
October 31, 2022
Study Start
February 22, 2023
Primary Completion
November 1, 2023
Study Completion
February 1, 2024
Last Updated
February 21, 2023
Record last verified: 2023-02