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

NCT07041749 | Not Yet Recruiting DMC

• 1 other identifier: Drugs in tt of plantar warts
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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)

Conditions

Warts of Foot

Outcome Measures

Primary Outcomes (1)

• 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

  2 years

Secondary Outcomes (1)

• Recurrence rate

  2 years

Study Arms (3)

Group A

PLACEBO COMPARATOR

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

Device: Microneedling alone

Group B

ACTIVE COMPARATOR

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

Drug: Bleomycin; Device: Microneedling alone

Group c

ACTIVE COMPARATOR

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

Device: Microneedling alone; Drug: 5 fluorouracil

Interventions

Bleomycin DRUG

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

Group B

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.

Group A; Group B; Group c

5 fluorouracil DRUG

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

Group c

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: people aged 18 or above 18 years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Interventions

Bleomycin; Percutaneous Collagen Induction; Fluorouracil

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Punctures; Rehabilitation; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Rofaida Refaat Shehata, Assistant professor

  Assiut University

  STUDY DIRECTOR

• Amira ali abdelmotaleb, professor

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

aya magdi mohamed, resident doctor

CONTACT

01023856887; ayamagdi349@gmail.com

Amira Ali Abdelmotaleb, Professor

CONTACT

01005263721; amiraali21@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor at Dermatology, Venereology and Andrology department

Model Details: 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 .

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: June 27, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share