A Phase 2/3 interventional study of Human Papillomavirus 9-valent Vaccine, Recombinant and Normal Saline in Warts, sponsored by Western Institute for Veterans Research. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-05.
Sponsored by Western Institute for Veterans Research · Phase 2/3, Interventional, and Treatment
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.
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.
184 studies on the registry are indexed under Warts; 29 are open to participants now.
This study's planned enrollment of 120 is above the median of 70 across 163 interventional studies indexed under Warts.
Browse Warts studies →Western Institute for Veterans Research is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
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
0.5-mL normal saline administered as intramuscular injection at weeks 0, 4, and 20
Other: Normal Saline
0.5-mL suspension of 9-valent Gardasil administered as intramuscular injection at weeks 0, 4, and 20
Also known as: Gardasil 9, 9-valent Gardasil
0.5-mL normal saline administered as intramuscular injection at weeks 0, 4, and 20
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)
Time frame: 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)
Time frame: 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)
Time frame: Response to treatment assessments will occur at 8 weeks after first dose of vaccine/placebo
Skindex-16
Assessing for changes in quality of life, as indicated by the Skindex-16 questionnaire
Time frame: 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
Time frame: Safety assessment will occur at 0, 4, 8, 20, and 24 weeks
Started Mar 2024 (actual). Primary completion is estimated for Dec 2025, 21 months after the start.
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Studies of the drug tested here: Human Papillomavirus Recombinant Vaccine nonavalent
Western Institute for Veterans Research