Plantar WartNCT05057663
Intralesional Treatment of Plantar Wart
A study testing Bleomycin and 5-fluorouracil in people with Plantar Wart, run by Sohag University at 1 site in Egypt.
Trial summary
Group 1; intralesional injection of bleomycin in plantar wart. Group 2; intralesional injection of 5-fluorouracil in plantar wart Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Plantar Wart
- What is being tested?
- Bleomycin and 5-fluorouracil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2021to 1 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects must meet all of the following criteria to be considered for participation in this study.
- Subject is able to comprehend and is willing to sign an informed consent/assent for participation in this study.
- Male or female ≥ 8 years old.
- Subject has a clinical diagnosis of common warts.
- 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:
- Each wart must have a longest axis that is ≥ 3mm and ≤ 8 mm and have a thickness of ≤3mm
Show all 17Show fewer
- Each wart must be a discrete lesion
- Each wart must be present for at least 4 weeks
- Not be covered with hair which, in the investigator's opinion, would interfere with the study medication treatment or the study evaluations
- Not be in an intertriginous fold
- Be the only common wart present when the circular cutout template is centered over the wart
- The Target and Non-Target Warts must have a PWA ≥ 2.
- 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.
- 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.
- Subject is non-pregnant and non-lactating.
- 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.
- Subject is willing and able to follow all study instructions and to attend all study visits.
Who cannot join
- Subjects are excluded from this study if any 1 or more of the following criteria is met:
- Subject has clinically atypical warts on the trunk or extremities.
- Subject is immunocompromised (e.g., due to chemotherapy, systemic steroids, genetic immunodeficiency, transplant
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Sohag Faculty of Medicine
Sohag
Rania Farouk, resident, 01283074271, rania_farouk_post@med.sohag.edu.eg
About this study
Official title: Intralesional Injection of Bleomycin Versus 5-fluorouracil in Treatment of Plantar Wart; a Comparative Study
Group 1; intralesional injection of bleomycin in plantar wart. Group 2; intralesional injection of 5-fluorouracil in plantar wart
- Conditions
- Plantar Wart
- Being tested
- Bleomycin and 5-fluorouracil
- Keywords
- Intralesional Injection., Bleomycin., 5-Fluorouracil.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bleomycin and 5-fluorouracilDrug
In the bleomycin-treated group, bleomycin vial will be diluted first with 5 ml distilled water At time of treatment session 2 ml of lidocaine 2% and 1 ml of the bleomycin stock solution will be taken in 100-unite insulin syringe. Thus, the working bleomycin solution will be used in treatment 1 mg/ml. The bleomycin solution will be injected intralesional till blanching of the wart will be occurred. The amount of injection ranging from 0.2, 0.5, 1 ml according to size of warts; (5 mm, 10 mm, >10 mm) maximum for 1 ml in single wart and 2ml in treatment session. Treatment session will be done every two weeks maximum four sessions.
In 5-fluorouracil treated group, 5-fluorouracil vial ( 1 ml of 50 mg/ml 5-FU will be mixed with 0.25 ml of lidcaine 2% Every wart will be injected with 0.1 ml of the previous mixture into it base using an insulin syringe till blanching of the warts maximum 2ml of 5-FU per session. Treatment session will be done every two week for maximum 6 sessions
| Study group | Role | What they receive |
|---|---|---|
| Bleomycin group | Active comparator | Not described Receives: Drug: Bleomycin and 5-fluorouracil |
| 5-Fluorouracil group | Active comparator | Not described Receives: Drug: Bleomycin and 5-fluorouracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to intralesional injection of bleomycin, 5fluorouracil in treatment of plantar wart
Physician's Wart Assessment Grade Descriptor 0 Clear: No visible wart. No further treatment is indicated
- Near Clear: A visible wart that is less than 3mm in maximal diameter (or length)
- A visible wart ≥ 3mm and <6 mm in maximal diameter (or length)
- A visible wart ≥ 6mm in maximal diameter (or length)
Measured: 3monthes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start1 Nov 2021 (estimated)
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Sep 2022 (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 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Farouk Daif, Sohag University
- Investigators
- Rania Farouk, Resident, Principal investigator, Sohag Faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05057663
- Sponsor's protocol ID
- Soh-Med-21-09-03
- Status last verified
- Sep 2021
- First submitted
- 12 Sep 2021
- Last updated
- 28 Sep 2021
- 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 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intralesional Injection of Bleomycin Versus 5-fluorouracil in Treatment of Plantar Wart; a Comparative Study
- ClinicalTrials.gov ID
- NCT05057663
- Acronym / sponsor ID
- Soh-Med-21-09-03
- Conditions
- Plantar Wart
- Keywords
- Intralesional Injection., Bleomycin., 5-Fluorouracil.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 27 Sep 2021 (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.
Group 1; intralesional injection of bleomycin in plantar wart. Group 2; intralesional injection of 5-fluorouracil in plantar wart
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bleomycin group | Active comparator | Drug: Bleomycin and 5-fluorouracil |
| 5-Fluorouracil group | Active comparator | Drug: Bleomycin and 5-fluorouracil |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- Subjects must meet all of the following criteria to be considered for participation in this study.
- Subject is able to comprehend and is willing to sign an informed consent/assent for participation in this study.
- Male or female ≥ 8 years old.
- Subject has a clinical diagnosis of common warts.
- 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:
Key exclusion criteria (3 listed)
- Subject has clinically atypical warts on the trunk or extremities.
- Subject is immunocompromised (e.g., due to chemotherapy, systemic steroids, genetic immunodeficiency, transplant
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 |
|---|---|---|
| Bleomycin and 5-fluorouracilIn the bleomycin-treated group, bleomycin vial will be diluted first with 5 ml distilled water At time of treatment session 2 ml of lidocaine 2% and 1 ml of the bleomycin stock solution will be taken in 100-unite insulin syringe. Thus, the working bleomycin solution will be used in treatment 1 mg/ml. The bleomycin solution will be injected intralesional till blanching of the wart will be occurred. The amount of injection ranging from 0.2, 0.5, 1 ml according to size of warts; (5 mm, 10 mm, >10 mm) maximum for 1 ml in single wart and 2ml in treatment session. Treatment session will be done every two weeks maximum four sessions. In 5-fluorouracil treated group, 5-fluorouracil vial ( 1 ml of 50 mg/ml 5-FU will be mixed with 0.25 ml of lidcaine 2% Every wart will be injected with 0.1 ml of the previous mixture into it base using an insulin syringe till blanching of the warts maximum 2ml of 5-FU per session. Treatment session will be done every two week for maximum 6 sessions | Drug | 5-Fluorouracil group, Bleomycin group |
Primary outcome
Response to intralesional injection of bleomycin, 5fluorouracil in treatment of plantar wart
Time frame: 3monthes
Physician's Wart Assessment Grade Descriptor 0 Clear: No visible wart. No further treatment is indicated 1. Near Clear: A visible wart that is less than 3mm in maximal diameter (or length) 2. A visible wart ≥ 3mm and <6 mm in maximal diameter (or length) 3. A visible wart ≥ 6mm in maximal diameter (or length)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
Related trials for Plantar Wart
Recruiting
Liquid Nitrogen Cryotherapy Versus CO₂ Laser for Palmoplantar Warts
Palmoplantar Warts
Not yet recruitingPhase 3
Intralesional Acyclovir Versus Intralesional Zinc Sulphate in the Treatment of Plantar Warts
Warts, Plantar Warts
Not yet recruitingPhase 3
Hydrogen Peroxide 40% Versus Salicylic Acid 40% for Plantar Warts
Plantar Wart
RecruitingPhase 4
Randomized, Placebo-controlled, Double Blind Study to Evaluate the Efficacy of 2LVERU®JUNIOR and 2LVERU® on the Treatment of Warts
Common Wart, Flat Wart
RecruitingPhase 4
Intralesional Therapies For Cutaneous Viral Warts: A Comparative Analysis Of Vitamin D3 And Acyclovir
Viral Wart, Plantar Wart
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.
Rania Farouk, Resident principal investigator
Sohag Faculty of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bleomycin 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 17 inclusion and 3 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 28 Sep 2021. 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 Rania Farouk, Resident (01283074271, rania_farouk_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?
Response to intralesional injection of bleomycin, 5fluorouracil in treatment of plantar wart (time frame: 3monthes). 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 28 Sep 2021.