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Not yet recruitingNCT07396714Updated Feb 9, 2026

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

An Early Phase 1 interventional study of Ivermectin and microneedling in Warts, sponsored by Assiut University. Not yet recruiting. Open to participants aged 11 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-02-09.

Sponsored by Assiut University · Early Phase 1, Interventional, and Treatment

Phase
Early Phase 1
Study type
Interventional
Enrollment
88
Allocation
Randomized
Ages
11 Years to 80 Years
Sex
All
01

Study summary

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)

Read the 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.

02

Conditions studied

  • Warts

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Keywords

  • topical ivermectin with microneedling in warts treatment
03

In context

Warts

171 studies on the registry are indexed under Warts; 35 are open to participants now.

This study's planned enrollment of 88 is above the median of 70 across 155 interventional studies indexed under Warts.

Browse Warts studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
11 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
88 participants (estimated)

Study arms

  • Experimental
    topical ivermectin

    Drug: Ivermectin

  • Experimental
    microneedling

    patients with cutaneous warts will be treated with microneedling.

    Device: microneedling

  • Experimental
    microneedling with ivermectin

    patients with cutaneous warts will be treated with topical ivermectin with microneedling.

    Drug: Ivermectin · Device: microneedling

  • Active comparator
    topical salicylic acid

    patients with cutaneous warts will be treated with topical salicylic acid.

    Drug: Salicylic Acid

Interventions

  • 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

  • Devicemicroneedling

    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

  • 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

06

What researchers measure

Primary outcomes

  1. evaluation of the efficacy of topical ivermectin in treatment of cutaneous warts.

    clinical assessment of warts at the baseline \& each visit comparing photographs at different timeline .

    Time frame: baseline

Secondary outcomes

  1. evaluation of the efficacy of topical ivermectin combined with microneedling in treatment of cutaneous warts.

    clinical assessment of warts at the baseline \& at each visit every 2 weeks

    Time frame: baseline

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

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

Related links

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07396714
Lead sponsor
Assiut University
Responsible party
Aya Mohamed Sayed Abdelaziz (Doctor, Assiut University) — Principal investigator
First posted
Feb 9, 2026
Start date
Feb 1, 2026 (estimated)
Primary completion
Feb 1, 2027 (estimated)
Completion
Jun 1, 2027 (estimated)
Last update
Feb 9, 2026

Study contacts

aya mohamed sayed, bechlor
Contact
aya.m.abdelazia17@gmail.com
01010556275 ext. +2
Alaa mohamed ghazaly, MD
study director · Assiut University
Ayman Mohamed Mahran, MD
study director · Assiut University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Ivermectin

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