the Efficacy of Ivermectin Alone or With Microneedling in Treatment of Cutaneous Warts.

February 4, 2026 updated by: Aya Mohamed Sayed Abdelaziz, Assiut University

Evaluation of the Efficacy & Safety of Topical Ivermectin Alone or in Combination With Microneedling as Novel Therapeutic Options for Cutaneous Non-genital Warts Versus Topical Salicylic Acid ؛ Randomized Controlled Clinical Trial.

To compare between the efficacy and safety of topical ivermectin alone, microneedling with topical ivermectin and topical salicylic acid in treatment of cutaneous warts.

topical ivermectin 1% will be applied on warts whole night clinical assessment will be done every 2 weeks

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 topical ivermectin 1% will be applied on to the wart tissue.

Sessions: Sessions will be performed every 2 weeks until complete cure or for maximum 6 sessions (total 3 month)

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Wart is a benign skin growth caused by infection with the human papillomavirus (HPV). These lesions typically appear as rough, raised projections on the skin, often on the hands, feet, or other areas. More than 200 types of HPV have been identified.

Worldwide, warts (due to HPV) are extremely common. Estimates suggest about 7-12% of the global population have cutaneous warts at any given time, and among school-aged children the prevalence can reach 10-20%.

The main types of cutaneous non genital warts are : Common warts, often appears on hands &fingers ,Plantar warts: occur on the soles of the feet, Flat warts occur often on the face, legs.

Warts cause pain (especially plantar types), cosmetic embarrassment, in addition to risk of transmission to others There are several therapeutic modalities for warts: include destructive agents (keratolytics, cryotherapy, curettage and cautery, laser, photodynamic therapy), antimitotic agents (podophyllin, bleomycin, retinoids), immune stimulants (topical sensitizers, cimetidine), and topical virucidal agents (formaldehyde, glutaraldehyde) No single treatment is effective in most of patients, available options often painful ,associated with recurrence and have risks like scarring or infection.

Ivermectin, which is traditionally used as an anti- helminthic agent, has been found to have a range of effects beyond its initial well known anti-parasitic use, that include: immune modulatory, anti-viral and anti- proliferative effect. The immune modulatory effect of Ivermectin depends on it's ability to modulate pro-inflammatory cytokines. It also has antiviral role by inhibition of viral replication, several studies have addressed its antiviral activity against a diverse range of viruses, leading to its exploration for use in treating SARS-CoV-2 during the most recent global pandemic .

Emerging literature highlights the potential use of ivermectin as a promising candidate for anticancer therapy through inhibition of the proliferation of the tumour cells by regulating multiple signalling pathways.

In dermatology topical ivermectin is approved by the U.S. Food and Drug Administration (FDA) for the treatment of hair lice & rosacea.

The anti-proliferative & antiviral activity of ivermectin suggests it's use in the treatment of HPV infection. Oral ivermectin demonstrated efficacy in a case study for treatment of resistant cutaneous warts, 10 patients clinically diagnosed cutaneous warts were enrolled. Each patient received oral ivermectin at a dose of 200 μg/kg body weight once daily for 3 weeks .Results indicated a substantial reduction in the number and size of warts in 8 patients, 4 patients of them experienced complete resolution of their warts. The efficacy of topical ivermectin in treatment of cutaneous warts still uncovered.

Microneedling is also an effective treatment option for HPV by Immune activation: Micro-injuries initiate a localized inflammatory and wound-healing response, which can enhance the immune system's ability to recognize and clear human papillomavirus (HPV)-infected cells. It also enhance drug penetration: When paired with topical agents (e.g., bleomycin, 5 fluorouracil, methotrexate), microneedling facilitates deeper and more uniform penetration into the wart tissue. This increases drug effectiveness while potentially reducing systemic side effects.

This study will be conducted to explore the potential efficacy of topical ivermectin 1% either alone or in combination with assist delivery via microneedling in treatment of non genital cutaneous warts.

Study Type

Interventional

Enrollment (Estimated)

88

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • patients with cutaneous non genital warts aged 11:80 y.
  • No concurrent systemic or topical treatment of warts

Exclusion Criteria:

  • Genital warts.

    • Pregnancy and lactation.
    • History of any bleeding, clotting disorder or using anticoagulants
    • Chronic systemic diseases such as chronic renal failure, hepaticinsufficiency, and cardiovascular disorders.
    • patients who received any treatment for warts in the last month before the study.
    • Patients with history of neuropathy or peripheral ischemia.
    • Patients with signs of inflammation or infection.
    • Patients with history of a serious systemic or anaphylactic reaction or allergy to ivermectin.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: topical ivermectin
Drug: Ivermectin
patients with non-genital cutaneous warts will be treated by topical application of ivermectin : topical ivermectin 1% will be applied under occlusion overnight daily then revaluated every 2 weeks for maximum 12 weeks
Experimental: microneedling
patients with cutaneous warts will be treated with microneedling.
Device: microneedling
patients with non-genital cutaneous warts will be treated by microneedling (2mm depth) every 2-weeks until complete clearance or for a maximum of 12weeks
Experimental: microneedling with ivermectin
patients with cutaneous warts will be treated with topical ivermectin with microneedling.
Drug: Ivermectin
patients with non-genital cutaneous warts will be treated by topical application of ivermectin : topical ivermectin 1% will be applied under occlusion overnight daily then revaluated every 2 weeks for maximum 12 weeks
Device: microneedling
patients with non-genital cutaneous warts will be treated by microneedling (2mm depth) every 2-weeks until complete clearance or for a maximum of 12weeks
Active Comparator: topical salicylic acid
patients with cutaneous warts will be treated with topical salicylic acid.
Drug: Salicylic Acid
patients with non-genital cutaneous warts will be treated by topical application of ivermectin : cotton soaked with topical salicylic acid will be applied under occlusion overnight daily then revaluated every 2 weeks for maximum 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
evaluation of the efficacy of topical ivermectin in treatment of cutaneous warts.
Time Frame: baseline
clinical assessment of warts at the baseline & each visit comparing photographs at different timeline .
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
evaluation of the efficacy of topical ivermectin combined with microneedling in treatment of cutaneous warts.
Time Frame: baseline
clinical assessment of warts at the baseline & at each visit every 2 weeks
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Alaa mohamed ghazaly, MD, Assiut University
  • Study Director: Ayman Mohamed Mahran, MD, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Mehta N. Case study of oral ivermectin in patients with cutaneous warts. J Cardiovasc Dis Res. 2024;15(12):6438-46

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

January 28, 2026

First Submitted That Met QC Criteria

February 4, 2026

First Posted (Actual)

February 9, 2026

Study Record Updates

Last Update Posted (Actual)

February 9, 2026

Last Update Submitted That Met QC Criteria

February 4, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ivermectin for cutaneous warts

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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