Abstract
BackgroundHuman papilloma viruses (HPVs) infect squamous epithelial cells and form verrucous lesions, or warts. Besides the psychosocial problems caused by the disfiguring warts, a subset of HPVs can be the primary etiologic agent for malignancies such as cervical cancer. However, there is no curative antiviral therapy for HPV infection. We recently found that the viral RNA transcription of DNA viruses requires cyclin dependent kinase 9 (CDK9) in the host cells, and that FIT039, a specific inhibitor of CDK9, suppressed the proliferation of DNA viruses such as herpes simplex virus 1 (HSV-1), HSV-2, human adenovirus, human cytomegalovirus, hepatitis virus B, and HPVs. Here, we describe a protocol to evaluate the safety and antiviral effect of FIT039 on common warts in human skin.Methods and designA multi-institutional, single-blind, placebo-controlled randomized phase I/II clinical trial was designed to evaluate the safety and efficacy of FIT039 on common warts on the extremities. A total of 44 adults with a primary diagnosis of verruca vulgaris on the extremities without serious comorbidities will be randomized into either the intervention group with an FIT039-releasing transdermal patch or a control group for a duration of 14 days. Outcomes will be assessed at baseline and postintervention. Participants will be further assessed at 2 months follow-up. The primary endpoint for efficacy is the resolution of the warts. The safety endpoint is the incidence of adverse events and adverse drug reactions. The secondary endpoints are changes in the dimensions of the wart, the cross-sectional area of the wart, and the number of clots within the area of the wart.DiscussionThis study is the first to assess the efficacy of FIT039 and will contribute to the development of antiviral agents that can cure refractory common warts in immunocompromised patients.Trial registrationUMIN Clinical Trials, UMIN000029695. Registered on 1 November 2017.
Highlights
Human papilloma viruses (HPVs) infect squamous epithelial cells and form verrucous lesions, or warts
This study is the first to assess the efficacy of FIT039 and will contribute to the development of antiviral agents that can cure refractory common warts in immunocompromised patients
As we recently found that FIT039 suppresses the proliferation of HPV in the raft culture, we are performing a clinical trial to examine the efficacy of FIT039 on common warts in the skin [14]
Summary
Human papilloma viruses (HPVs) infect squamous epithelial cells and form verrucous lesions, or warts. A human vaccine is available with more than 90% efficacy for the prevention of type-specific genital HPV infection and the development of associated dysplasia [2,3,4,5]. A meta-analysis of clinical trials of salicylic acid formulations versus placebo showed that the former significantly increased the chance of the clearance of warts at all sites (risk ratio (RR) 1.56, 95% confidence interval (CI) 1.20–2.03) [9]. Topical salicylic acid and cryotherapy are the most common approach to treating skin warts. Their efficacies are not high, and the patients often experience recurrences. Evidence is not sufficient for other chemicals such as citric acid, formic acid, silver nitrate, zinc oxide, and zinc sulfate [8]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
