Plantar WartNCT05520658
Evaluation of the Efficacy of Intralesional Injection of Combined Digoxin and Furosemide Versus 5 - Fluorouracil in Treatment of Plantar Warts
A study testing combined digoxin and furosemide and 5 fluorouracil in people with Plantar Wart, run by Sohag University at 1 site in Egypt.
Trial summary
Warts are common skin infections caused by human papillomavirus (HPV), which can cause a variety of skin presentations according to its type, site and the immune status .Nongenital warts may be presented as common, plane, plantar, filiform, or mucosal warts .Most people are affected by cutaneous warts, either plantar… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Plantar Wart
- What is being tested?
- combined digoxin and furosemide and 5 fluorouracil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2022to Sep 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age:>18 years .
- Sex: both males and females will be included.
- Confirmed diagnosis by clinical and dermoscopic examination of plantar warts will be made
Who cannot join
- Patients with history or evidenced hypersensitivity to any component used in this study.
- Pregnancy \& lactating.
- Patients who receive immune suppressive therapy.
- Patients who receive any wart treatment during the last 2 months before enrollment in the study.
- Patients with systemic illness especially cardiac patients.
- Patients who refused participation in the study
Trial locations and contacts
1 site in 1 country.
Essam A Nada contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag University Hospital
Sohag
Osama R Elshrif, professor
About this study
Warts are common skin infections caused by human papillomavirus (HPV), which can cause a variety of skin presentations according to its type, site and the immune status .Nongenital warts may be presented as common, plane, plantar, filiform, or mucosal warts .Most people are affected by cutaneous warts, either plantar warts or common warts .prevalence of skin warts is between 3% and 13% and plantar warts are about 30% of skin warts in western world .Majority of cases occur in adolescent and young adults
- Conditions
- Plantar Wart
- Being tested
- combined digoxin and furosemide, 5 fluorouracil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combined digoxin and furosemideDrug
one session every 2 weeks for maximum 6 sessions
5 fluorouracilDrug
5 fluorouracil mixed with1ml of 2% lignocaine and epinephrine one session every 2 weeks for maximum 6 sessions .
| Study group | Role | What they receive |
|---|---|---|
| group A | Active comparator | patients will receive intralesional combined digoxin and furosemide , one session every 2 weeks for maximum 6 sessions Receives: Drug: combined digoxin and furosemide |
| group B | Active comparator | patients will receive intralesional 5 fluorouracil mixed with 1ml of 2% lignocaine and epinephrine one session every 2 weeks for maximum 6 sessions . Receives: Drug: 5 fluorouracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change in size of plantar wart
measurement the change in size of plantar wart
Measured: 3 month
the change in number of plantar warts
measurement the change in number of plantar warts
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2022
- Study start1 Jul 2022
- Primary completionSep 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Plantar WartStudies of the same condition, open and under way.
- More trials run by Sohag 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
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samah Ragab Ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05520658
- Sponsor's protocol ID
- Soh-Med-22-07-01
- Status last verified
- Aug 2022
- First submitted
- 15 Aug 2022
- Last updated
- 30 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Abeck D, Tetsch L, Luftl M, Biedermann T. Extragenital cutaneous warts - clinical presentation, diagnosis and treatment. J Dtsch Dermatol Ges. 2019 Jun;17(6):613-634. doi: 10.1111/ddg.13878.
PubMed 31241843Kwok CS, Holland R, Gibbs S. Efficacy of topical treatments for cutaneous warts: a meta-analysis and pooled analysis of randomized controlled trials. Br J Dermatol. 2011 Aug;165(2):233-46. doi: 10.1111/j.1365-2133.2011.10218.x. Epub 2011 May 26.
PubMed 21219294
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Intralesional Injection of Combined Digoxin and Furosemide Versus 5 - Fluorouracil in Treatment of Plantar Warts
- ClinicalTrials.gov ID
- NCT05520658
- Acronym / sponsor ID
- Soh-Med-22-07-01
- Conditions
- Plantar Wart
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 30 Aug 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.
Warts are common skin infections caused by human papillomavirus (HPV), which can cause a variety of skin presentations according to its type, site and the immune status .Nongenital warts may be presented as common, plane, plantar, filiform, or mucosal warts .Most people are affected by cutaneous warts, either plantar warts or common warts .prevalence of skin warts is between 3% and 13% and plantar warts are about 30% of skin warts in western world .Majority of cases occur in adolescent and young adults
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Active comparator | Drug: combined digoxin and furosemidepatients will receive intralesional combined digoxin and furosemide , one session every 2 weeks for maximum 6 sessions |
| group B | Active comparator | Drug: 5 fluorouracilpatients will receive intralesional 5 fluorouracil mixed with 1ml of 2% lignocaine and epinephrine one session every 2 weeks for maximum 6 sessions . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age:>18 years .
- Sex: both males and females will be included.
- Confirmed diagnosis by clinical and dermoscopic examination of plantar warts will be made
Key exclusion criteria (6 listed)
- Patients with history or evidenced hypersensitivity to any component used in this study.
- Pregnancy \& lactating.
- Patients who receive immune suppressive therapy.
- Patients who receive any wart treatment during the last 2 months before enrollment in the study.
- Patients with systemic illness especially cardiac patients.
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 |
|---|---|---|
| combined digoxin and furosemideone session every 2 weeks for maximum 6 sessions | Drug | group A |
| 5 fluorouracil5 fluorouracil mixed with1ml of 2% lignocaine and epinephrine one session every 2 weeks for maximum 6 sessions . | Drug | group B |
Primary outcome
the change in size of plantar wart
Time frame: 3 month
measurement the change in size of plantar wart
the change in number of plantar warts
Time frame: 3 month
measurement the change in number of plantar warts
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2022.
- Background: PubMed 31241843Abeck D, Tetsch L, Luftl M, Biedermann T. Extragenital cutaneous warts - clinical presentation, diagnosis and treatment. J Dtsch Dermatol Ges. 2019 Jun;17(6):613-634. doi: 10.1111/ddg.13878.
- Background: PubMed 21219294Kwok CS, Holland R, Gibbs S. Efficacy of topical treatments for cutaneous warts: a meta-analysis and pooled analysis of randomized controlled trials. Br J Dermatol. 2011 Aug;165(2):233-46. doi: 10.1111/j.1365-2133.2011.10218.x. Epub 2011 May 26.
- Individual participant dataSharing planned: Undecided
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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.
Essam A Nada contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing combined digoxin and furosemide and 5 fluorouracil in people with Plantar Wart, run by Sohag University at 1 site in Egypt.
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 3 inclusion and 6 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 30 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 samah R Ahmed, resident (01128636414, samah_ragab_post@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the change in size of plantar wart (time frame: 3 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05520658, which also lists 2 linked publications.
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 30 Aug 2022.