Human Papillomavirus (HPV) Vaccination vs. Placebo for the Treatment of Refractory Cutaneous Warts

Study Overview
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Brief Summary
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This double-blinded clinical trial randomly assigns participants with refractory cutaneous warts to receive either treatment with the human papillomavirus (HPV) vaccine or a placebo to assess the efficacy of HPV vaccination for the treatment of refractory cutaneous warts.

Detailed Description
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Cutaneous warts are a common cause for medical office visits and are frequently encountered in dermatology practice. Despite their benign nature, cutaneous warts can be painful, disfiguring, persistent and may be associated with significant morbidity. Numerous therapeutic options are available, including local destruction, virucidal agents, topical and systemic antiproliferative medications, and immunotherapy. Unfortunately, no single therapy is uniformly effective, and patients often receive multiple courses of treatment (cryotherapy, curettage, Candida antigen injection, etc.) without improvement. An efficacious therapy for cutaneous warts is sorely needed and treatment with HPV vaccination is being increasingly reported. Notably, individual cases and case series have reported complete resolution of multiple treatment refractory warts after treatment with the quadrivalent HPV vaccine. Even more encouraging, a larger retrospective study of 30 patients found that up to 60% of patients had a complete or partial response after treatment with the HPV vaccine. Additional benefits of treatment with HPV vaccination include ease of use, less tissue destruction and pain, and the potential for less frequent medical office visits. Despite these promising preliminary data, a larger, randomized controlled study has yet to be performed. This will be a multi-center, double-blinded, randomized, placebo-controlled trial with 120 participants. Enrolled participants will be randomized to treatment with either HPV vaccination or placebo. Participants will receive injections with the 9-valent HPV vaccine or placebo at 0, 4, and 20 weeks and follow up until 24 weeks to determine their treatment response, quality of life and the safety and tolerability of HPV vaccination.

Official Title
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Human Papillomavirus (HPV) Vaccination for the Treatment of Refractory Cutaneous Warts: A Randomized, Placebo-Controlled, Double-Blinded Trial

Conditions
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Warts

Intervention / Treatment
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* Biological: Human Papillomavirus 9-valent Vaccine, Recombinant
* Other: Normal Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be able to understand and provide written informed consent Age 18 or older Clinical diagnosis of cutaneous warts Must have received prior treatment for cutaneous warts (such as curettage, cryotherapy, salicylic acid, intralesional Candida antigen injection, etc.) Exclusion Criteria: Untreated cutaneous warts Anogenital warts Oral warts Treatment for cutaneous warts in the past 4 weeks Active acute illness Immunosuppression Known hypersensitivity to HPV vaccination Subjects may not receive any other investigational treatment Pregnancy or planned pregnancy during the study period

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HPV Vaccine<br>0.5-mL suspension of 9-valent Gardasil vaccine administered as intramuscular injection at weeks 0, 4, and 20 | Biological: Human Papillomavirus 9-valent Vaccine, Recombinant<br>* 0.5-mL suspension of 9-valent Gardasil administered as intramuscular injection at weeks 0, 4, and 20<br>* Other names: 9-valent Gardasil;|
| Placebo Comparator: Placebo<br>0.5-mL normal saline administered as intramuscular injection at weeks 0, 4, and 20 | Other: Normal Saline<br>* 0.5-mL normal saline administered as intramuscular injection at weeks 0, 4, and 20<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessing the efficacy/therapeutic response of HPV vaccination for the treatment of refractory cutaneous warts (response information may be found in description) at 24 weeks | Assessing the efficacy/therapeutic response of HPV vaccination for the treatment of refractory cutaneous warts, classified as: (1) complete response (CR; complete clearance of warts); (2) partial response (PR; any decrease in lesion number or size); or (3) no response (NR; no change or increase in lesion number or size) | Response to treatment assessments will occur 24 weeks after first dose of vaccine/placebo (primary endpoint) | 
| Assessing the efficacy/therapeutic response of HPV vaccination for the treatment of refractory cutaneous warts (response information may be found in description) at 4 weeks | Assessing the efficacy/therapeutic response of HPV vaccination for the treatment of refractory cutaneous warts, classified as: (1) complete response (CR; complete clearance of warts); (2) partial response (PR; any decrease in lesion number or size); or (3) no response (NR; no change or increase in lesion number or size) | Response to treatment assessments will occur 4 weeks after first dose of vaccine/placebo | 
| Assessing the efficacy/therapeutic response of HPV vaccination for the treatment of refractory cutaneous warts (response information may be found in description) at 8 weeks | Assessing the efficacy/therapeutic response of HPV vaccination for the treatment of refractory cutaneous warts, classified as: (1) complete response (CR; complete clearance of warts); (2) partial response (PR; any decrease in lesion number or size); or (3) no response (NR; no change or increase in lesion number or size) | Response to treatment assessments will occur at 8 weeks after first dose of vaccine/placebo | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skindex-16 | Assessing for changes in quality of life, as indicated by the Skindex-16 questionnaire | Quality of life assessments will occur at 0 (baseline), 4, 8, and 24 weeks (primary endpoint) | 
| Incidence of Treatment-Emergent Adverse Events | Assessing the safety and tolerability of HPV vaccination via adverse event reporting | Safety assessment will occur at 0, 4, 8, 20, and 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Refractory cutaneous warts, Human Papillomavirus (HPV) Vaccination, HPV vaccine