About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.)

Disqualifiers

Untreated cutaneous warts

Anogenital warts

Oral warts

Treatment for cutaneous warts in the past 4 weeks

Trial design

Design model

Parallel

Treatments tested in this trial

Human Papillomavirus 9-valent Vaccine, Recombinant
Biological/Vaccine
0.5-mL suspension of 9-valent Gardasil administered as intramuscular injection at weeks 0, 4, and 20
Normal Saline
Other intervention
0.5-mL normal saline administered as intramuscular injection at weeks 0, 4, and 20

Treatment groups

120 Participants

are divided into 2 treatment groups

Group A: HPV VaccineExperimental treatment 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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)

2

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

3

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

Secondary outcomes

1

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)

2

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

Human Papillomavirus (HPV) Vaccination vs. Placebo for the Treatment of Refractory Cutaneous Warts

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts