Warts
Conditions
Keywords
Refractory cutaneous warts, Human Papillomavirus (HPV) Vaccination, HPV vaccine
Brief summary
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
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.
Interventions
0.5-mL suspension of 9-valent Gardasil administered as intramuscular injection at weeks 0, 4, and 20
OTHERNormal Saline
0.5-mL normal saline administered as intramuscular injection at weeks 0, 4, and 20
Sponsors
University of Utah
Merck Sharp & Dohme LLC
Western Institute for Veterans Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Investigators and Nurses share the role as Care Provider. Investigators will be blinded to the treatment allocation. Nurses, however, will be aware of the treatment allocation as they are administering the injections. Nurses are not involved in the study conduct in any other way.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Must be able to understand and provide written informed consent 2. Age 18 or older 3. Clinical diagnosis of cutaneous warts 4. Must have received prior treatment for cutaneous warts (such as curettage, cryotherapy, salicylic acid, intralesional Candida antigen injection, etc.)
Exclusion criteria
1. Untreated cutaneous warts 2. Anogenital warts 3. Oral warts 4. Treatment for cutaneous warts in the past 4 weeks 5. Active acute illness 6. Immunosuppression 7. Known hypersensitivity to HPV vaccination 8. Subjects may not receive any other investigational treatment 9. Pregnancy or planned pregnancy during the study period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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, 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) |
| 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 | 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, 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) |
| 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 | Response to treatment assessments will occur at 8 weeks after first dose of vaccine/placebo | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Skindex-16 | Quality of life assessments will occur at 0 (baseline), 4, 8, and 24 weeks (primary endpoint) | Assessing for changes in quality of life, as indicated by the Skindex-16 questionnaire |
| Incidence of Treatment-Emergent Adverse Events | Safety assessment will occur at 0, 4, 8, 20, and 24 weeks | Assessing the safety and tolerability of HPV vaccination via adverse event reporting |
Countries
United States
Contacts
Primary ContactLowell Nicholson, MD
Backup ContactJamie Rhoads, MD
Outcome results
None listed