- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07307131
Furosemide-Digoxin vs. Polidocanol for Cutaneous Warts
December 29, 2025 updated by: Ghada Mohamed Shams, Benha University
A Head-to-Head Comparison of Intralesional Furosemide-Digoxin Versus Polidocanol for the Treatment of Cutaneous Warts With 6-Month Follow-up
This study compares the effectiveness and safety of two different intralesional treatments for cutaneous warts: a combination of furosemide and digoxin versus polidocanol.
Study Overview
Status
Completed
Conditions
Detailed Description
This is a prospective, randomized, single-blind, comparative clinical study to evaluate the efficacy and safety of intralesional combined furosemide-digoxin versus intralesional polidocanol in the treatment of cutaneous warts.
Sixty-four adult patients were randomized to receive one of the two treatments every two weeks for a maximum of four sessions.
The main goal was to see which treatment was better at completely clearing the warts.
The study also looked at side effects and how often the warts came back within six months.
Study Type
Interventional
Enrollment (Actual)
64
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Qalyubia Governorate
-
Banhā, Qalyubia Governorate, Egypt, 13518
- Faculty of medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients over 18 years of age with single or multiple cutaneous warts.
Exclusion Criteria:
- History of allergies to the study medications, known cardiac or renal disease, hypertension, pregnancy or lactation, and any signs of systemic or local infection.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Furosemide and digoxin
Intralesional combined furosemide (10 mg/ml) and digoxin (0.25 mg/ml)
|
Group A (Experimental): Intralesional combined furosemide (10 mg/ml) and digoxin (0.25 mg/ml)
|
|
Active Comparator: Polidocanol
Intralesional Polidocanol 2%
|
Group B (Active Comparator): Intralesional polidocanol 2%
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Complete Clinical Response
Time Frame: Up to 8 weeks
|
100% clearance of the treated wart at the end of the treatment period.
|
Up to 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence and Severity of Adverse Effects
Time Frame: Throughout the treatment period (up to 8 weeks)
|
Assessment of side effects such as pain, erythema, edema, and ulceration.
|
Throughout the treatment period (up to 8 weeks)
|
|
Recurrence Rate
Time Frame: 6 months post-treatment
|
Rate of wart recurrence at the 6-month follow-up visit
|
6 months post-treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ghada Shams, MD, Benha University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2024
Primary Completion (Actual)
March 1, 2025
Study Completion (Actual)
September 30, 2025
Study Registration Dates
First Submitted
December 14, 2025
First Submitted That Met QC Criteria
December 14, 2025
First Posted (Estimated)
December 29, 2025
Study Record Updates
Last Update Posted (Estimated)
January 2, 2026
Last Update Submitted That Met QC Criteria
December 29, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- intralesional treatment warts
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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