WartsEarly Phase 1NCT07396714
the Efficacy of Ivermectin Alone or With Microneedling in Treatment of Cutaneous Warts.
A Early Phase 1 study testing Ivermectin, microneedling and Salicylic Acid in people with Warts, run by Assiut University.
Trial 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… Read more about this study
- Who is it for?
- Ages 11 to 80 years
- Conditions the study is for
- Warts
- What is being tested?
- Ivermectin, microneedling and Salicylic Acid
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to 1 Jun 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with cutaneous non genital warts aged 11:80 y.
- No concurrent systemic or topical treatment of warts
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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)
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.
- Conditions
- Warts
- Being tested
- Ivermectin, microneedling, Salicylic Acid
- Keywords
- topical ivermectin with microneedling in warts treatment
- Medical subject headings
- Warts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IvermectinDrug
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
microneedlingDevice
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
Salicylic AcidDrug
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
| Study group | Role | What they receive |
|---|---|---|
| topical ivermectin | Experimental | Not described Receives: Drug: Ivermectin |
| microneedling | Experimental | patients with cutaneous warts will be treated with microneedling. Receives: Device: microneedling |
| microneedling with ivermectin | Experimental | patients with cutaneous warts will be treated with topical ivermectin with microneedling. Receives: Drug: Ivermectin; Device: microneedling |
| topical salicylic acid | Active comparator | patients with cutaneous warts will be treated with topical salicylic acid. Receives: Drug: Salicylic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: 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
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start1 Feb 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for WartsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Mohamed Sayed Abdelaziz, Assiut University
- Investigators
- Alaa mohamed ghazaly, MD, Study director, Assiut UniversityAyman Mohamed Mahran, MD, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07396714
- Sponsor's protocol ID
- ivermectin for cutaneous warts
- Status last verified
- Jan 2026
- First submitted
- 28 Jan 2026
- Last updated
- 9 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mehta N. Case study of oral ivermectin in patients with cutaneous warts. J Cardiovasc Dis Res. 2024;15(12):6438-46
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07396714
- Acronym / sponsor ID
- ivermectin for cutaneous warts
- Conditions
- Warts
- Keywords
- topical ivermectin with microneedling in warts treatment
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| topical ivermectin | Experimental | Drug: Ivermectin |
| microneedling | Experimental | Device: microneedlingpatients with cutaneous warts will be treated with microneedling. |
| microneedling with ivermectin | Experimental | Drug: Ivermectin, Device: microneedlingpatients with cutaneous warts will be treated with topical ivermectin with microneedling. |
| topical salicylic acid | Active comparator | Drug: Salicylic Acidpatients with cutaneous warts will be treated with topical salicylic acid. |
Who may qualify
- Ages
- 11 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- patients with cutaneous non genital warts aged 11:80 y.
- No concurrent systemic or topical treatment of warts
Key exclusion criteria (8 listed)
- Genital warts.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ivermectinpatients 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 | Drug | microneedling with ivermectin, topical ivermectin |
| microneedlingpatients with non-genital cutaneous warts will be treated by microneedling (2mm depth) every 2-weeks until complete clearance or for a maximum of 12weeks | Device | microneedling, microneedling with ivermectin |
| Salicylic Acidpatients 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 | Drug | topical salicylic acid |
Primary outcome
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 .
1 secondary outcome
evaluation of the efficacy of topical ivermectin combined with microneedling in treatment of cutaneous warts.
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- BackgroundMehta N. Case study of oral ivermectin in patients with cutaneous warts. J Cardiovasc Dis Res. 2024;15(12):6438-46
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alaa mohamed ghazaly, MD study director
Assiut University
Ayman Mohamed Mahran, MD study director
Assiut University
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Ivermectin, microneedling and Salicylic Acid in people with Warts, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact aya mohamed sayed, bechlor (01010556275 ext. +2, aya.m.abdelazia17@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluation of the efficacy of topical ivermectin in treatment of cutaneous warts. (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07396714, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.