Efficacy and Safety of Oral Ivermectin for Genital Warts

October 28, 2026 updated by: Ahmad Yar, University of Health Sciences Lahore

Efficacy And Safety Of Oral Ivermectin For The Treatment Of Genital Warts

This study aims to evaluate the efficacy and safety of oral ivermectin in adults with recalcitrant genital warts that have not responded to conventional treatments. A total of 90 participants will receive oral ivermectin (200 µg/kg) once weekly for four weeks. Treatment response will be assessed by changes in wart number and size at weeks 2, 4, and 8. Potential adverse effects, recurrence, and patient satisfaction will also be evaluated. The study will help assess the potential role of oral ivermectin in treating persistent or recurrent genital warts.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Genital warts, also known as condylomata acuminata, are benign epithelial growths associated with human papillomavirus (HPV), particularly types 6 and 11. They affect the anogenital region and may adversely affect sexual health, psychological well-being, and quality of life. Available treatment options include topical therapies, cryotherapy, electrosurgery, and laser ablation. However, treatment failure and recurrence remain clinical challenges.

Ivermectin is an antiparasitic agent used to treat several parasitic infections. Although it is not an established antiviral treatment, experimental studies have suggested potential immunomodulatory and antiviral properties. Previous reports have described improvement in cutaneous warts following oral ivermectin treatment. However, evidence supporting its use for genital warts remains limited, and its efficacy and safety for this indication have not been adequately established.

This quasi-experimental study will evaluate the efficacy and safety of oral ivermectin in patients with recalcitrant or recurrent genital warts that have not completely cleared following at least one conventional treatment, including imiquimod or cryotherapy.

The planned sample size is 90 participants, recruited using non-probability consecutive sampling. Eligible participants will be adults aged 18-60 years with clinically diagnosed external genital or perianal warts confirmed by a consultant dermatologist. Patients with known ivermectin hypersensitivity, pregnancy or lactation, severe hepatic or renal impairment, interfering genital skin conditions, immunocompromised status, or concurrent immunosuppressive medication or other antiviral therapy will be excluded.

After institutional ethical review board and CPSP approval and written informed consent, demographic and clinical information will be recorded using a structured proforma. Baseline assessments will include the duration of genital warts, history of recurrence, previous treatments, anatomical location, lesion count, and lesion size. The largest diameter of target lesions will be measured in millimetres, and standardized digital photographs will be obtained for comparison during follow-up.

All enrolled participants will receive oral ivermectin at 200 micrograms per kilogram of body weight once weekly for four weeks. Follow-up assessments will take place at weeks 2, 4, and 8. At each visit, wart number and size will be reassessed, new lesions will be documented, and participants will be monitored for adverse effects.

Treatment response at week 8 will be classified as:

Complete response: Clearance of all clinically visible genital warts.

Partial response: At least a 50% reduction in the total number of lesions and/or the measured size of target lesions compared with baseline.

No response: Less than a 50% reduction in wart number or size, no change, or an increase in lesions.

The primary efficacy outcome will be the proportion of participants achieving complete response at week 8. Secondary outcomes will include partial response, changes in wart number and size, development of new lesions, recurrence, and patient satisfaction measured on a numerical rating scale from 0 to 10.

Safety will be assessed by recording the type, frequency, and severity of adverse events, including gastrointestinal symptoms, nausea, vomiting, abdominal pain, dizziness, headache, skin rash, and pruritus. Treatment discontinuation due to adverse effects and serious adverse events will also be documented.

Data will be entered and analysed using IBM SPSS Statistics version 26.0. Quantitative variables will be summarized using means and standard deviations or medians and interquartile ranges, as appropriate. Categorical variables will be summarized as frequencies and percentages. Changes in wart number and size over time will be analysed using repeated-measures ANOVA or the Friedman test, as appropriate, with paired comparisons conducted using suitable statistical tests. Treatment-response proportions will be reported with 95% confidence intervals. Stratified analyses will assess potential effect modifiers, including age, gender, disease duration, baseline wart burden, recurrence status, and previous treatment. A p-value of 0.05 or less will be considered statistically significant.

The planned study duration is six months after CPSP approval. The study is intended to generate clinical evidence regarding the potential efficacy and safety of oral ivermectin for recalcitrant genital warts.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

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

Study Contact Backup

Study Locations

  • Pakistan
    • Punjab Province
      • Faisalābad, Punjab Province, Pakistan, 38000
        • Madinah Teaching Hospital, Faisalabad
        • Contact:
          • Madinah Teaching Hospital, Faisalabad
          • Phone Number: +92 41 8869861
          • Email: info@mth.org.pk

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

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults aged 18 to 60 years.
  • Patients with clinically diagnosed external genital or perianal warts, confirmed by a consultant dermatologist.
  • Recalcitrant or recurrent lesions unresponsive to at least one conventional treatment (imiquimod, cryotherapy).
  • Hemodynamically stable with no active systemic illness.

Exclusion Criteria:

  • Known allergy or hypersensitivity to ivermectin.
  • Pregnant or lactating women.
  • Patients with severe hepatic or renal impairment.
  • Presence of other dermatologic conditions in the genital area that may interfere with evaluation (e.g., lichen planus, psoriasis).
  • Immunocompromised individuals (HIV-positive, organ transplant recipients).
  • Concurrent use of immunosuppressive medications or other antiviral therapy during the study.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Oral Ivermectin for Genital Warts

Participants with recalcitrant or recurrent genital warts will receive oral ivermectin at a dose of 200 µg/kg body weight once weekly for four weeks. Treatment efficacy and safety will be assessed at baseline and at weeks 2, 4, and 8. Wart number and size, treatment response, new lesions, recurrence, patient satisfaction, and adverse effects will be documented. Copy
Drug: Ivermectin

Oral ivermectin administered at a dose of 200 µg/kg body weight once weekly for four weeks to adults with recalcitrant or recurrent genital warts that have not completely responded to conventional treatment. Treatment efficacy and safety will be assessed at baseline and at weeks 2, 4, and 8 by evaluating wart number and size, treatment response, new lesions, recurrence, patient satisfaction, and adverse effects. Copy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Wart Clearance
Time Frame: 8 weeks after treatment initiation

Proportion of participants achieving complete clearance of all clinically visible genital warts following oral ivermectin treatment. Complete response is defined as 100% clearance of all clinically visible genital warts compared with baseline.
8 weeks after treatment initiation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Partial Wart Response
Time Frame: 8 weeks after treatment initiation

Proportion of participants achieving at least a 50% reduction in the total number of genital warts and/or the measured size of target lesions compared with baseline.
8 weeks after treatment initiation
Reduction in Wart Number
Time Frame: Baseline, weeks 2, 4, and 8 after treatment initiation

Change in the total number of clinically visible genital warts from baseline, assessed by direct lesion count at follow-up visits.
Baseline, weeks 2, 4, and 8 after treatment initiation
Reduction in Wart Size
Time Frame: Baseline, weeks 2, 4, and 8 after treatment initiation

Change in the size of target genital warts from baseline, measured in millimetres using the largest diameter of the lesions.
Baseline, weeks 2, 4, and 8 after treatment initiation
Development of New Lesions
Time Frame: Weeks 2, 4, and 8 after treatment initiation

Proportion of participants developing new genital wart lesions during the treatment and follow-up period, as documented during clinical assessments.
Weeks 2, 4, and 8 after treatment initiation
Recurrence
Time Frame: Through week 8

Proportion of participants experiencing recurrence of genital warts during the study period, as documented in the study proforma.
Through week 8
Adverse Effects
Time Frame: Weeks 2, 4, and 8 after treatment initiation

Proportion of participants experiencing adverse effects following oral ivermectin administration, including gastrointestinal symptoms, dizziness, headache, skin rash, and pruritus. The type, frequency, and severity of adverse effects will be recorded.
Weeks 2, 4, and 8 after treatment initiation

Collaborators and Investigators

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

Sponsor

University of Health Sciences Lahore

Investigators

  • Study Chair: Tanzeela Khalid, Madinah Teaching Hospital, Faisalabad

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

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 20, 2027

Primary Completion (Estimated)

October 20, 2027

Study Completion (Estimated)

November 1, 2027

Study Registration Dates

First Submitted

October 28, 2026

First Submitted That Met QC Criteria

October 28, 2026

First Posted (Actual)

November 3, 2026

Study Record Updates

Last Update Posted (Actual)

November 3, 2026

Last Update Submitted That Met QC Criteria

October 28, 2026

Last Verified

October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-12-2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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