Plantar WartNCT05599971
Intralesional Injection of Combined Digoxin and Furosemide Versus 5-Flurouracil in Plantar Warts
A study testing intralesional combined digoxin and furosemide, intralesional injection of 5- Fluorouracil and intralesional saline in people with Plantar Wart, run by Zagazig University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Plantar Wart
- What is being tested?
- intralesional combined digoxin and furosemide, intralesional injection of 5- Fluorouracil and intralesional saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 22 Feb 2023to 1 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with multiple plantar warts (≥ 3) will be included.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Efficacy of Intralesional Injection of Combined Digoxin and Furosemide Versus 5-Flurouracil in the Treatment of Plantar Warts
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.
Read the detailed description
Warts are benign proliferations of skin and mucosa caused by the human papilloma virus (HPV). Currently, over 170 HPV types have been identified. Certain HPV types tend to infect skin at specific anatomical sites, such as palmoplantar warts, which are typically caused by serotypes 1, 2, and 4, however warts caused by any HPV type can occur at any site (Tulay \& Serakinci, 2016).
Plantar warts most commonly present with pain that occur with activities that put pressure on the soles of the feet. They commonly affect plantar areas of increased pressure, such as the heels or metatarsal heads. On gross inspection, plantar warts may appear as a singular rough, flesh-colored to yellow or grey-brown, hyperkeratotic papule, or a thickened "cobblestoned" plaque, termed a mosaic wart, which consists of multiple plantar warts that have coalesced (Witchey et al., 2018).
There are several modalities for the treatment of warts including, cryotherapy, electrocoagulation, topical salicylic acid, topical 5-fluorouracil, intralesional immunotherapy, and laser surgery. All these treatment options can be painful, time-consuming, and/or expensive, and none is considered the gold standard (Latif et al., 2021).
K+ influx is essential for the replication of DNA viruses, such as HPV. Both digoxin, which is a cardiac glycoside, and furosemide, which is a loop diuretic, inhibit the K+ influx by interacting with cell membrane ion co-transporters (Na+/K+-ATPase and Na+-K+-2Cl-co-transporter-1). Therefore, it is hypothesized that these two compounds may be valuable in the treatment of HPV-induced warts. This new approach is called ionic contra-viral therapy (Rijsbergen et al., 2019). Intralesional injection of combined digoxin and furosemide was found to be safe and effective as a treatment option for multiple plantar warts (Fathy et al., 2021).
5-Fluorouracil (5-FU) is an antimetabolite that can be used alone or with other chemotherapeutic agents to treat solid tumors. It is one of the pyrimidine analogues. Due to its structure, 5-FU disrupts nucleoside metabolism and can be integrated into the single and double helix of RNA and DNA, respectively, causing cell cytotoxicity and death (Zoheir et al., 2022).
Intralesional 5-fluorouarcil has been found to be a highly effective, safe and cheap alternative in the treatment of warts, with a significantly good response in genital warts also (Kamal et al., 2108).
- Conditions
- Plantar Wart
- Being tested
- intralesional combined digoxin and furosemide, intralesional injection of 5- Fluorouracil, intralesional saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intralesional combined digoxin and furosemideDrug
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.
intralesional injection of 5- FluorouracilDrug
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.
intralesional salineOther
15 patients will receive intralesional saline. Selected patients will receive one session every 2 weeks till complete clearance or up to 5 sessions.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | 15 patients will receive intralesional 0.1 mL of combined digoxin and furosemide, with maximum 5 warts per session. Receives: Drug: intralesional combined digoxin and furosemide |
| Group B | Active comparator | 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. Receives: Drug: intralesional injection of 5- Fluorouracil |
| Group c | Placebo comparator | 15 patients will receive intralesional saline. Receives: Other: intralesional saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in size of the warts
The studied warts will be clinically evaluated regarding change in size
Measured: 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).
Measured: through study completion, an average of 9 months
treatment-related adverse effects
Immediate and late adverse effects will be evaluated
Measured: 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).
Measured: through study completion, an average of 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start22 Feb 2023 (estimated)
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar WartStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Norhan Anees, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05599971
- Sponsor's protocol ID
- planter wart treatment
- Status last verified
- Feb 2023
- First submitted
- 19 Oct 2022
- Last updated
- 21 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Intralesional Injection of Combined Digoxin and Furosemide Versus 5-Flurouracil in the Treatment of Plantar Warts
- ClinicalTrials.gov ID
- NCT05599971
- Acronym / sponsor ID
- planter wart treatment
- Conditions
- Plantar Wart
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 22 Feb 2023 (estimated)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 31 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Warts are benign proliferations of skin and mucosa caused by the human papilloma virus (HPV). Currently, over 170 HPV types have been identified. Certain HPV types tend to infect skin at specific anatomical sites, such as palmoplantar warts, which are typically caused by serotypes 1, 2, and 4, however warts caused by any HPV type can occur at any site (Tulay \& Serakinci, 2016).
Plantar warts most commonly present with pain that occur with activities that put pressure on the soles of the feet. They commonly affect plantar areas of increased pressure, such as the heels or metatarsal heads. On gross inspection, plantar warts may appear as a singular rough, flesh-colored to yellow or grey-brown, hyperkeratotic papule, or a thickened "cobblestoned" plaque, termed a mosaic wart, which consists of multiple plantar warts that have coalesced (Witchey et al., 2018).
There are several modalities for the treatment of warts including, cryotherapy, electrocoagulation, topical salicylic acid, topical 5-fluorouracil, intralesional immunotherapy, and laser surgery. All these treatment options can be painful, time-consuming, and/or expensive, and none is considered the gold standard (Latif et al., 2021).
K+ influx is essential for the replication of DNA viruses, such as HPV. Both digoxin, which is a cardiac glycoside, and furosemide, which is a loop diuretic, inhibit the K+ influx by interacting with cell membrane ion co-transporters (Na+/K+-ATPase and Na+-K+-2Cl-co-transporter-1). Therefore, it is hypothesized that these two compounds may be valuable in the treatment of HPV-induced warts. This new approach is called ionic contra-viral therapy (Rijsbergen et al., 2019). Intralesional injection of combined digoxin and furosemide was found to be safe and effective as a treatment option for multiple plantar warts (Fathy et al., 2021).
5-Fluorouracil (5-FU) is an antimetabolite that can be used alone or with other chemotherapeutic agents to treat solid tumors. It is one of the pyrimidine analogues. Due to its structure, 5-FU disrupts nucleoside metabolism and can be integrated into the single and double helix of RNA and DNA, respectively, causing cell cytotoxicity and death (Zoheir et al., 2022).
Intralesional 5-fluorouarcil has been found to be a highly effective, safe and cheap alternative in the treatment of warts, with a significantly good response in genital warts also (Kamal et al., 2108).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: intralesional combined digoxin and furosemide15 patients will receive intralesional 0.1 mL of combined digoxin and furosemide, with maximum 5 warts per session. |
| Group B | Active comparator | Drug: intralesional injection of 5- Fluorouracil15 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 comparator | Other: intralesional saline15 patients will receive intralesional saline. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with multiple plantar warts (≥ 3) will be included.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intralesional combined digoxin and furosemide15 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. | Drug | Group A |
| intralesional injection of 5- Fluorouracil15 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. | Drug | Group B |
| intralesional saline15 patients will receive intralesional saline. Selected patients will receive one session every 2 weeks till complete clearance or up to 5 sessions. | Other | Group c |
Primary outcome
change in size of the warts
Time frame: through study completion, an average of 9 months
The studied warts will be clinically evaluated regarding change in size
Dermoscopic evaluation
Time frame: through study completion, an average of 9 months
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).
treatment-related adverse effects
Time frame: through study completion, an average of 9 months
Immediate and late adverse effects will be evaluated
Patients' satisfaction
Time frame: through study completion, an average of 9 months
Patients' satisfaction will be evaluated through a questionnaire. Patients' satisfaction will be graded into (very satisfied, satisfied, and unsatisfied).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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Randomized, Placebo-controlled, Double Blind Study to Evaluate the Efficacy of 2LVERU®JUNIOR and 2LVERU® on the Treatment of Warts
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing intralesional combined digoxin and furosemide, intralesional injection of 5- Fluorouracil and intralesional saline in people with Plantar Wart, run by Zagazig University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nourhan AN Anis, MD (0201149947355, norhan_hn_as@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in size of the warts (time frame: through study completion, an average of 9 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.