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

NCT ID: NCT07041749

Last Updated: 2025-06-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-06-01
• Study Completion Date: 2027-07-01

Brief 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. 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.

Conditions

Warts of Foot

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group A

(n=20); will be treated with combination of microneedling with saline.

Group Type: PLACEBO_COMPARATOR

Microneedling alone

Intervention Type: 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.

Group B

(n=20);will be treated with combination of microneedling and topical bleomycin.

Group Type: ACTIVE_COMPARATOR

Bleomycin

Intervention Type: DRUG

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

Microneedling alone

Intervention Type: 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.

Group c

(n=20);will be treated with combination of microneedling and topical 5-flurouracil .

Group Type: ACTIVE_COMPARATOR

Microneedling alone

Intervention Type: 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

Intervention Type: DRUG

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

Interventions

Bleomycin

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

Intervention Type: DRUG

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.

Intervention Type: DEVICE

5 fluorouracil

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

Intervention Type: DRUG

Eligibility Criteria

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.

4. Impaired wound healing or imunosuppresion. 5.Patients who received any treatment for warts in the last month before study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Aya magdi mohamed mahmoud

resident doctor at Dermatology, Venereology and Andrology department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rofaida Refaat Shehata, Assistant professor

Role: STUDY_DIRECTOR

Assiut University

Amira ali abdelmotaleb, professor

Role: STUDY_DIRECTOR

Assiut University

Central Contacts

aya magdi mohamed, resident doctor

Role: CONTACT

ayamagdi349@gmail.com

01023856887

Amira Ali Abdelmotaleb, Professor

Role: CONTACT

amiraali21@aun.edu.eg

01005263721

Other Identifiers

Drugs in tt of plantar warts

Identifier Type: -

Identifier Source: org_study_id