Clinical trial NCT05625633: Human Papillomavirus (HPV) Vaccination vs. Placebo for the Treatment of Refractory Cutaneous Warts
Official title: Human Papillomavirus (HPV) Vaccination for the Treatment of Refractory Cutaneous Warts: A Randomized, Placebo-Controlled, Double-Blinded Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Warts
Keywords: Refractory cutaneous warts
Human Papillomavirus (HPV) Vaccination
HPV vaccine
Lead sponsor: Western Institute for Veterans Research
Sponsor class: OTHER
Collaborators: name: University of Utah
name: Merck Sharp & Dohme LLC
First posted: 2022-11-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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
timeFrame: Response to treatment assessments will occur 24 weeks after first dose of vaccine/placebo (primary endpoint)
measure: 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
timeFrame: Response to treatment assessments will occur 4 weeks after first dose of vaccine/placebo
measure: 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
timeFrame: Response to treatment assessments will occur at 8 weeks after first dose of vaccine/placebo
Secondary outcomes:
measure: Skindex-16
timeFrame: Quality of life assessments will occur at 0 (baseline), 4, 8, and 24 weeks (primary endpoint)
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: Safety assessment will occur at 0, 4, 8, 20, and 24 weeks
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah Midvalley Health Center
state: Utah
city: Salt Lake City
country: United States
facility: VA Salt Lake City Health Care System
state: Utah
Study officials:
affiliation: University of Utah Health Care System
name: Lowell Nicholson, MD
role: PRINCIPAL_INVESTIGATOR
References: