Trial Title:
Human Papillomavirus (HPV) Vaccination vs. Placebo for the Treatment of Refractory Cutaneous Warts
NCT ID:
NCT05625633
Condition:
Warts
Conditions: Official terms:
Warts
Conditions: Keywords:
Refractory cutaneous warts
Human Papillomavirus (HPV) Vaccination
HPV vaccine
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Triple (Participant, 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.
Intervention:
Intervention type:
Biological
Intervention name:
Human Papillomavirus 9-valent Vaccine, Recombinant
Description:
0.5-mL suspension of 9-valent Gardasil administered as intramuscular injection at weeks
0, 4, and 20
Arm group label:
HPV Vaccine
Other name:
Gardasil 9
Other name:
9-valent Gardasil
Intervention type:
Other
Intervention name:
Normal Saline
Description:
0.5-mL normal saline administered as intramuscular injection at weeks 0, 4, and 20
Arm group label:
Placebo
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Utah Midvalley Health Center
Address:
City:
Salt Lake City
Zip:
84107
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lowell Nicholson, MD
Phone:
801-581-2121
Email:
lowell.nicholson@hsc.utah.edu
Investigator:
Last name:
Lowell Nicholson, MD
Email:
Principal Investigator
Investigator:
Last name:
Jamie Rhoads, MD
Email:
Sub-Investigator
Investigator:
Last name:
Stephanie Klein, MD
Email:
Sub-Investigator
Facility:
Name:
VA Salt Lake City Health Care System
Address:
City:
Salt Lake City
Zip:
84148
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jamie Rhoads, MD
Phone:
801-582-1565
Email:
jamie.rhoads@hsc.utah.edu
Investigator:
Last name:
Jamie Rhoads, MD
Email:
Principal Investigator
Investigator:
Last name:
Lowell Nicholson, MD
Email:
Sub-Investigator
Investigator:
Last name:
Stephanie Klein, MD
Email:
Sub-Investigator
Start date:
March 25, 2024
Completion date:
December 2026
Lead sponsor:
Agency:
Western Institute for Veterans Research
Agency class:
Other
Collaborator:
Agency:
University of Utah
Agency class:
Other
Collaborator:
Agency:
Merck Sharp & Dohme LLC
Agency class:
Industry
Source:
Western Institute for Veterans Research
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05625633
