Warts of Footplantar wartsNCT07041749
Microneedling Alone Versus Microneedling Coupled With Either Bleomycin or 5flourouracil in the Treatment of Plantar Warts
A study testing Bleomycin, Microneedling alone and 5 fluorouracil in people with Warts of Foot, run by Assiut University.
Trial summary
To compare between the efficacy and safety of microneedling alone, microneedling with topical bleomycin and microneedling with 5-flurouracil in treatment of planter warts. Microneedling will be performed on each wart using dermapen supplied with 12 needles arranged in rows. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Warts of Foot
- What is being tested?
- Bleomycin, Microneedling alone and 5 fluorouracil
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -
Who cannot join
- 1. Children below 18. 2.Pregnant and lactating women. 3.Patients with any systemic disease or immunocompromised Patients or patients receiving any immunosuppressive drugs.
- 4. Impaired wound healing or imunosuppresion. 5.Patients who received any treatment for warts in the last month before study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of the Efficacy of Microneedling Alone Versus Microneedling Coupled With Either Bleomycin or 5flourouracil in the Treatment of Plantar Warts
To compare between the efficacy and safety of microneedling alone, microneedling with topical bleomycin and microneedling with 5-flurouracil in treatment of planter warts.
Microneedling will be performed on each wart using dermapen supplied with 12 needles arranged in rows. Topical anesthetic cream will be applied for 60 min before the procedures. Microneedling will be performed on each wart using dermapen. The penetration depth will be adjusted at 2-mm, endpoint is pinpoint bleeding and the dermapen will be held by the hand in a vertical direction on the warts.
Read more
Bleomycin is typically supplied in 15 U vials. The preparation will be diluted first with 7 mL normal saline ,double the amount taken from the vial by adding the same amount lidocaine (2%), so that the concentrations become 1 U/mL . The maximum total amount of bleomycin taken to each patient in one session will be 1 U/1 mL . Microneedling will be performed on the lesion using a microneedling pen type device with a 1-cm tip diameter at a 2-mm depth setting for 2-3 minutes until pinpoint bleebing occurs 1 mL of the prepared solution of bleomycin (1 U/1 mL) will be dropped on to the wart tissue using insulin syringe and occlusion will be applied for 3 hours.
5-FU is available in 10 mL vial: 500 mg/10 mL. Application of 5-FU solution will be done by dropping using an insulin syringe (1 mL)to help dropping of the solution on the warts surface. Then, the lesion will be occluded with a plaster for 3 h.
Sessions: Sessions will be performed every 2 weeks until complete cure or for maximum 6 sessions (total 3 month)
Read the detailed description
Plantar warts are common cutaneous diseases on the sole caused by the human papillomavirus, with a high annual incidence rate of 14% . It is an extremely common problem which can be very painful and debilitating . HPV is a double-stranded DNA virus with more than 200 types being identified. The life cycle of HPV is closely associated with the proliferation and differentiation of epithelium. It often causes pain, which impairs quality of life of patients. First-choice treatments for common warts such as cryotherapy and salicylic acid have low-cure rates for plantar warts. Other treatments such as immunotherapy and intralesional bleomycin, which have compassionate use have higher cure rates.
Treatment for recalcitrant plantar warts remains a continuing challenge as the options for treatment have different levels of success.Topical medications and physical destruction of warts via cryotherapy, electrocautery, laser or photodynamic therapy are all common forms of treatment (Cureus,2023).
Bleomycin is an antibiotic derived from Streptomyces verticellus with antitumor and antiviral properties. It acts by DNA strand and leads to focal dermal necrosis, dyskeratosis and a neutrophil predominant inflammation .Bleomycin had been used since the seventies of last century for eliminating warts and despite almost six decades of use, yet reports and studies show discrepancies among cure rates that range from 0 up to 100% in certain circumstances. Blemoycin inhibits the deoxyribonucleic acid (DNA) and protein synthesis and hence can induce tissue death.
5-fluorouracil (5-FU) is an antimetabolite drug, used for several therapeutic purposes in dermatology, including premalignant and malignant lesions, keloid scars, vitiligo, and inflammatory skin diseases. Five-Fluorouracil (FU) is an antitumor agent blocks DNA synthesis by inhibition of pyrimidine and thymidine. Therefore, it inhibits cellular proliferation and replication. This action helps 5-FU to be used in the treatment of warts.
Microneedling is a fine needle that penetrates the skin to induce micro-injuries leading to production of collagen fibers and release of growth factors. Microneedling has been used as an adjuvant therapy helping a drug delivery and also used in treatment of various dermatologic diseases . Tissue injury by multiple needle punctures may induce local inflammation and a subsequent cell-mediated immune response against human papilloma virus.
- Conditions
- Warts of Foot
- Being tested
- Bleomycin, Microneedling alone, 5 fluorouracil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BleomycinDrug
);will be treated with combination of microneedling and topical bleomycin .
Microneedling aloneDevice
' Microneedling will be performed on each wart using dermapen supplied with 12 needles arranged in rows. Topical anesthetic cream will be applied for 60 min before the procedures. Microneedling will be performed on each wart using dermapen. The penetration depth will be adjusted at 2-mm, endpoint is pinpoint bleeding and the dermapen will be held by the hand in a vertical direction on the warts.
5 fluorouracilDrug
);will be treated with combination of microneedling and topical 5-flurouracil .
| Study group | Role | What they receive |
|---|---|---|
| Group A | Placebo comparator | (n=20); will be treated with combination of microneedling with saline. Receives: Device: Microneedling alone |
| Group B | Active comparator | (n=20);will be treated with combination of microneedling and topical bleomycin. Receives: Drug: Bleomycin; Device: Microneedling alone |
| Group c | Active comparator | (n=20);will be treated with combination of microneedling and topical 5-flurouracil . Receives: Device: Microneedling alone; Drug: 5 fluorouracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is the clinical response, specifically the decrease in the size of warts as measured by a ruler.
The response is categorized as:
Complete response: Disappearance of the wart and return of normal skin markings.
Partial response: 50% to 99% reduction in wart size.
No or minimal response: 0% to 49% decrease in wart size
Measured: 2 years
Secondary outcomes (1)
Recurrence rate
The appearance of new wart lesions at the treated sites after complete remission during the three-month follow-up period is recorded as recurrence
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Warts of FootStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Model description
- The sample will be randomly assigned into three equal groups : * Group A (n=20); will be treated with combination of microneedling with saline. * GroupB (n=20);will be treated with combination of microneedling and topical bleomycin. * Group C (n=20);will be treated with combination of microneedling and topical 5-flurouracil .
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya magdi mohamed mahmoud, Assiut University
- Investigators
- Rofaida Refaat Shehata, Assistant professor, Study director, Assiut UniversityAmira ali abdelmotaleb, professor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07041749
- Sponsor's protocol ID
- Drugs in tt of plantar warts
- Acronym
- plantar warts
- Status last verified
- Jun 2025
- First submitted
- 20 Mar 2025
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Microneedling Alone Versus Microneedling Coupled With Either Bleomycin or 5flourouracil in the Treatment of Plantar Warts
- ClinicalTrials.gov ID
- NCT07041749
- Acronym / sponsor ID
- plantar warts / Drugs in tt of plantar warts
- Conditions
- Warts of Foot
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 27 Jun 2025 (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.
To compare between the efficacy and safety of microneedling alone, microneedling with topical bleomycin and microneedling with 5-flurouracil in treatment of planter warts.
Microneedling will be performed on each wart using dermapen supplied with 12 needles arranged in rows. Topical anesthetic cream will be applied for 60 min before the procedures. Microneedling will be performed on each wart using dermapen. The penetration depth will be adjusted at 2-mm, endpoint is pinpoint bleeding and the dermapen will be held by the hand in a vertical direction on the warts.
Bleomycin is typically supplied in 15 U vials. The preparation will be diluted first with 7 mL normal saline ,double the amount taken from the vial by adding the same amount lidocaine (2%), so that the concentrations become 1 U/mL . The maximum total amount of bleomycin taken to each patient in one session will be 1 U/1 mL . Microneedling will be performed on the lesion using a microneedling pen type device with a 1-cm tip diameter at a 2-mm depth setting for 2-3 minutes until pinpoint bleebing occurs 1 mL of the prepared solution of bleomycin (1 U/1 mL) will be dropped on to the wart tissue using insulin syringe and occlusion will be applied for 3 hours.
5-FU is available in 10 mL vial: 500 mg/10 mL. Application of 5-FU solution will be done by dropping using an insulin syringe (1 mL)to help dropping of the solution on the warts surface. Then, the lesion will be occluded with a plaster for 3 h.
Sessions: Sessions will be performed every 2 weeks until complete cure or for maximum 6 sessions (total 3 month)
Detailed description
Plantar warts are common cutaneous diseases on the sole caused by the human papillomavirus, with a high annual incidence rate of 14% . It is an extremely common problem which can be very painful and debilitating . HPV is a double-stranded DNA virus with more than 200 types being identified. The life cycle of HPV is closely associated with the proliferation and differentiation of epithelium. It often causes pain, which impairs quality of life of patients. First-choice treatments for common warts such as cryotherapy and salicylic acid have low-cure rates for plantar warts. Other treatments such as immunotherapy and intralesional bleomycin, which have compassionate use have higher cure rates.
Treatment for recalcitrant plantar warts remains a continuing challenge as the options for treatment have different levels of success.Topical medications and physical destruction of warts via cryotherapy, electrocautery, laser or photodynamic therapy are all common forms of treatment (Cureus,2023).
Bleomycin is an antibiotic derived from Streptomyces verticellus with antitumor and antiviral properties. It acts by DNA strand and leads to focal dermal necrosis, dyskeratosis and a neutrophil predominant inflammation .Bleomycin had been used since the seventies of last century for eliminating warts and despite almost six decades of use, yet reports and studies show discrepancies among cure rates that range from 0 up to 100% in certain circumstances. Blemoycin inhibits the deoxyribonucleic acid (DNA) and protein synthesis and hence can induce tissue death.
5-fluorouracil (5-FU) is an antimetabolite drug, used for several therapeutic purposes in dermatology, including premalignant and malignant lesions, keloid scars, vitiligo, and inflammatory skin diseases. Five-Fluorouracil (FU) is an antitumor agent blocks DNA synthesis by inhibition of pyrimidine and thymidine. Therefore, it inhibits cellular proliferation and replication. This action helps 5-FU to be used in the treatment of warts.
Microneedling is a fine needle that penetrates the skin to induce micro-injuries leading to production of collagen fibers and release of growth factors. Microneedling has been used as an adjuvant therapy helping a drug delivery and also used in treatment of various dermatologic diseases . Tissue injury by multiple needle punctures may induce local inflammation and a subsequent cell-mediated immune response against human papilloma virus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- The sample will be randomly assigned into three equal groups : * Group A (n=20); will be treated with combination of microneedling with saline. * GroupB (n=20);will be treated with combination of microneedling and topical bleomycin. * Group C (n=20);will be treated with combination of microneedling and topical 5-flurouracil .
| Arm | Type | Receives |
|---|---|---|
| Group A | Placebo comparator | Device: Microneedling alone(n=20); will be treated with combination of microneedling with saline. |
| Group B | Active comparator | Drug: Bleomycin, Device: Microneedling alone(n=20);will be treated with combination of microneedling and topical bleomycin. |
| Group c | Active comparator | Device: Microneedling alone, Drug: 5 fluorouracil(n=20);will be treated with combination of microneedling and topical 5-flurouracil . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (2 listed)
- 1. Children below 18. 2.Pregnant and lactating women. 3.Patients with any systemic disease or immunocompromised Patients or patients receiving any immunosuppressive drugs.
- 4. Impaired wound healing or imunosuppresion. 5.Patients who received any treatment for warts in the last month before study.
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);will be treated with combination of microneedling and topical bleomycin . | Drug | Group B |
| Microneedling alone' Microneedling will be performed on each wart using dermapen supplied with 12 needles arranged in rows. Topical anesthetic cream will be applied for 60 min before the procedures. Microneedling will be performed on each wart using dermapen. The penetration depth will be adjusted at 2-mm, endpoint is pinpoint bleeding and the dermapen will be held by the hand in a vertical direction on the warts. | Device | Group A, Group B, Group c |
| 5 fluorouracil);will be treated with combination of microneedling and topical 5-flurouracil . | Drug | Group c |
Primary outcome
The primary outcome is the clinical response, specifically the decrease in the size of warts as measured by a ruler.
Time frame: 2 years
The response is categorized as: Complete response: Disappearance of the wart and return of normal skin markings. Partial response: 50% to 99% reduction in wart size. No or minimal response: 0% to 49% decrease in wart size
1 secondary outcome
Recurrence rate
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
- Individual participant dataSharing planned: Yes
Related trials for Warts of Foot
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.
Rofaida Refaat Shehata, Assistant professor study director
Assiut University
Amira ali abdelmotaleb, professor study director
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing Bleomycin, Microneedling alone and 5 fluorouracil in people with Warts of Foot, run by Assiut 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 2 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: opening soon, as of the sponsor's last update on 27 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact aya magdi mohamed, resident doctor (01023856887, ayamagdi349@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome is the clinical response, specifically the decrease in the size of warts as measured by a ruler. (time frame: 2 years). 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 27 Jun 2025.