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NCT Number: NCT07041749

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.

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)

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Key information

Conditions

Warts of Foot

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-

Exclusion criteria

  • 1. Children below 18. 2.Pregnant and lactating women. 3.Patients with any systemic disease or immunocompromised Patients or patients receiving any immunosuppressive drugs.
  • Impaired wound healing or imunosuppresion. 5.Patients who received any treatment for warts in the last month before study.

Treatment and study plan

Bleomycin

Drug

);will be treated with combination of microneedling and topical bleomycin .

Microneedling alone

Device

' 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 fluorouracil

Drug

);will be treated with combination of microneedling and topical 5-flurouracil .

Primary outcomes

  1. 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

Secondary outcomes

  1. Recurrence rate

    Time frame: 2 years

    The appearance of new wart lesions at the treated sites after complete remission during the three-month follow-up period is recorded as recurrence

Study contacts

Contact information is provided by the study sponsor or research team.

Amira Ali Abdelmotaleb, Professor

CONTACT

[email protected]

01005263721

aya magdi mohamed, resident doctor

CONTACT

[email protected]

01023856887

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Comparison of the Efficacy of Microneedling Alone Versus Microneedling Coupled With Either Bleomycin or 5flourouracil in the Treatment of Plantar Warts

Acronym: plantar warts

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 27, 2025
Registry last updated
Jun 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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