Efficacy and Safety of Oral Ivermectin for Genital Warts

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.