Evidence map›Paper›PMID 31399147›Full record

ArticleTrials2019

The efficacy of a cyclin dependent kinase 9 (CDK9) inhibitor, FIT039, on verruca vulgaris: study protocol for a randomized controlled trial.

Takashi Nomura, Eriko Sumi, Gyohei Egawa, Saeko Nakajima, Eiko Toichi, Ryuji Uozumi, Harue Tada, Takayuki Nakagawa, Masatoshi Hagiwara, Kenji Kabashima

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.3field-weighted citation impact, top 37% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 7 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 3 institutions in 1 country.

Takashi NomuraDepartment of Dermatology, Graduate School of Medicine, Kyoto University Faculty of Medicine, 54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto, 606-8507, Japan. tnomura@kuhp.kyoto-u.ac.jp.ORCID http://orcid.org/0000-0002-4004-1339
Eriko SumiInstitute for Advancement of Clinical and Translational Science (iACT), Kyoto University Hospital, 54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto, 606-8507, Japan. sumieri@kuhp.kyoto-u.ac.jp.
Gyohei EgawaDepartment of Dermatology, Graduate School of Medicine, Kyoto University Faculty of Medicine, 54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto, 606-8507, Japan.
Saeko NakajimaDepartment of Dermatology, Graduate School of Medicine, Kyoto University Faculty of Medicine, 54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto, 606-8507, Japan.
Eiko ToichiDepartment of Dermatology, Kyoto Medical Center, National Hospital Organization, 1-1 Fukakusa-Mukaihata-cho, Fushimi-ku, Kyoto, 612-8555, Japan.
Ryuji UozumiInstitute for Advancement of Clinical and Translational Science (iACT), Kyoto University Hospital, 54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto, 606-8507, Japan.
Harue TadaInstitute for Advancement of Clinical and Translational Science (iACT), Kyoto University Hospital, 54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto, 606-8507, Japan.
Takayuki NakagawaDepartment of Clinical Pharmacology and Therapeutics, Kyoto University Hospital, 54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto, 606-8507, Japan.
Masatoshi HagiwaraAnatomy and Developmental Biology, Graduate School of Medicine, Kyoto University Faculty of Medicine, 54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto, 606-8507, Japan.
Kenji KabashimaDepartment of Dermatology, Graduate School of Medicine, Kyoto University Faculty of Medicine, 54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto, 606-8507, Japan.
Kyoto University · JPKyoto University Hospital · JPKyoto Medical Center · JP

Funding

KinoPharma Inc., Tokyo, Japan Not applicable
6 · The paper itself

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. DISCUSSION: 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.

trial registrationUMIN Clinical Trials, UMIN000029695 . Registered on 1 November 2017.

Indexed as

Antiviral AgentsCyclin-Dependent Kinase 9PyridinesWartsAdultClinical Trials, Phase I as TopicClinical Trials, Phase II as TopicHumansMulticenter Studies as TopicRandomized Controlled Trials as TopicResearch DesignSingle-Blind MethodAntiviral AgentsCyclin-Dependent Kinase 9FIT-039PyridinesCyclin dependent kinase 9 (CDK9)FIT039Human papilloma virus (HPV)Verruca vulgaris

Identifiers

PMID31399147
PMCPMC6688352
OpenAlexW2968628229

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.