- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05625633
Human Papillomavirus (HPV) Vaccination vs. Placebo for the Treatment of Refractory Cutaneous Warts
Human Papillomavirus (HPV) Vaccination for the Treatment of Refractory Cutaneous Warts: A Randomized, Placebo-Controlled, Double-Blinded Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Contact
- Name: Lowell Nicholson, MD
- Phone Number: 801-581-2121
- Email: lowell.nicholson@hsc.utah.edu
Study Contact Backup
- Name: Jamie Rhoads, MD
- Phone Number: 801-581-2121
- Email: jamie.rhoads@hsc.utah.edu
Study Locations
-
-
Utah
-
Salt Lake City, Utah, United States, 84148
- Recruiting
- VA Salt Lake City Health Care System
-
Principal Investigator:
- Jamie Rhoads, MD
-
Sub-Investigator:
- Stephanie Klein, MD
-
Contact:
- Jamie Rhoads, MD
- Phone Number: 801-582-1565
- Email: jamie.rhoads@hsc.utah.edu
-
Sub-Investigator:
- Lowell Nicholson, MD
-
Salt Lake City, Utah, United States, 84107
- Recruiting
- University of Utah Midvalley Health Center
-
Contact:
- Lowell Nicholson, MD
- Phone Number: 801-581-2121
- Email: lowell.nicholson@hsc.utah.edu
-
Principal Investigator:
- Lowell Nicholson, MD
-
Sub-Investigator:
- Jamie Rhoads, MD
-
Sub-Investigator:
- Stephanie Klein, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HPV Vaccine
0.5-mL suspension of 9-valent Gardasil vaccine administered as intramuscular injection at weeks 0, 4, and 20
|
0.5-mL suspension of 9-valent Gardasil administered as intramuscular injection at weeks 0, 4, and 20
Other Names:
|
Placebo Comparator: Placebo
0.5-mL normal saline administered as intramuscular injection at weeks 0, 4, and 20
|
0.5-mL normal saline administered as intramuscular injection at weeks 0, 4, and 20
|
What is the study measuring?
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
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, 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
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, 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
Time Frame: 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)
|
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
Time Frame: 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
|
Quality of life assessments will occur at 0 (baseline), 4, 8, and 24 weeks (primary endpoint)
|
Incidence of Treatment-Emergent Adverse Events
Time Frame: Safety assessment will occur at 0, 4, 8, 20, and 24 weeks
|
Assessing the safety and tolerability of HPV vaccination via adverse event reporting
|
Safety assessment will occur at 0, 4, 8, 20, and 24 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Lowell Nicholson, MD, University of Utah Health Care System
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB_00152954
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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