Evidence map›Paper›PMID 34909725›Full record

Trial reportJID innovations : skin science from molecules to population health2021

Safety and Efficacy of FIT039 for Verruca Vulgaris: A Placebo-Controlled, Phase I/II Randomized Controlled Trial.

Takashi Nomura, Eriko Sumi, Gyohei Egawa, Saeko Nakajima, Eiko Toichi, Nana Inoue, Mami Shibuya, Natsuko Okamoto, Tsuyoshi Mitsuishi, Ryuji Uozumi and 9 more

Open access · goldAbstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in JID innovations : skin science from molecules to population health, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.2field-weighted citation impact, top 54% 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

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. Trial
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

19 authors at 9 institutions in 2 countries.

Takashi NomuraDepartment of Dermatology, Graduate School of Medicine and Faculty of Medicine, Kyoto University, Kyoto, Japan.
Eriko SumiInstitute for Advancement of Clinical and Translational Science (iACT), Kyoto University Hospital, Kyoto, Japan.
Gyohei EgawaDepartment of Dermatology, Graduate School of Medicine and Faculty of Medicine, Kyoto University, Kyoto, Japan.
Saeko NakajimaDepartment of Dermatology, Graduate School of Medicine and Faculty of Medicine, Kyoto University, Kyoto, Japan.
Eiko ToichiDepartment of Dermatology, Kyoto Medical Center, National Hospital Organization, Kyoto, Japan.
Nana InoueDepartment of Dermatology, Kyoto Medical Center, National Hospital Organization, Kyoto, Japan.
Mami ShibuyaDepartment of Dermatology, Kyoto Medical Center, National Hospital Organization, Kyoto, Japan.
Natsuko OkamotoDepartment of Dermatology, Kyoto Medical Center, National Hospital Organization, Kyoto, Japan.
Tsuyoshi MitsuishiDepartment of Dermatology, Yachiyo Medical Center, Tokyo Women's Medical University, Yachiyo, Japan.
Ryuji UozumiInstitute for Advancement of Clinical and Translational Science (iACT), Kyoto University Hospital, Kyoto, Japan.
Harue TadaInstitute for Advancement of Clinical and Translational Science (iACT), Kyoto University Hospital, Kyoto, Japan.
Takayuki NakagawaDepartment of Clinical Pharmacology and Therapeutics, Kyoto University Hospital, Kyoto, Japan.
Nobuhiro KusubaDepartment of Dermatology, Otsu Red Cross Hospital, Otsu, Japan.
Aika OkunoDepartment of Dermatology, Takatsuki Red Cross Hospital, Takatsuki, Japan.
Chihiro ShimizuhiraDepartment of Dermatology, Rakuwakai Otowa Hospital, Kyoto, Japan.
Makiko IshikawaDepartment of Dermatology, Kyoto Katsura Hospital, Kyoto, Japan.
Shiro TanakaDepartment of Clinical Biostatistics, Graduate School of Medicine and Faculty of Medicine, Kyoto University, Kyoto, Japan.
Masatoshi HagiwaraDepartment of Anatomy and Developmental Biology, Graduate School of Medicine and Faculty of Medicine, Kyoto University, Kyoto, Japan.
Kenji KabashimaDepartment of Dermatology, Graduate School of Medicine and Faculty of Medicine, Kyoto University, Kyoto, Japan.
Kyoto University · JPKyoto Medical Center · JPKyoto University Hospital · JPAgency for Science, Technology and Research · SGKyoto Katsura Hospital · JPOtsu Red Cross Hospital · JPRakuwakai Otowa Hospital · JPTakatsuki Red Cross Hospital · JPTokyo Women's Medical University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

TRIAL

designHuman papillomavirus infection causes verruca vulgaris. CDK9 inhibitor FIT039 inhibits DNA virus proliferation in animal models. We conducted a multicenter, single-blind, placebo-controlled, randomized phase I/II clinical trial evaluating the safety and efficacy of FIT039 against verruca vulgaris.

methodsTarget lesions were treated with liquid nitrogen once, and a FIT039 patch or placebo patch was applied for 14 days. The primary endpoint was lesion disappearance. The secondary endpoints were safety and changes in dimension, cross-sectional area, and the number of petechial lesions.

resultsA total of 24 participants were randomly allocated to the FIT039 (n = 13, median age, 54 years) and placebo (n = 11, median age, 62 years) groups. Verruca vulgaris did not disappear. FIT039 decreased the dimension to 76% of the initial value on day 29, followed by an increase to 98% on day 57. Placebo showed a monotonic increase to 107% on day 57. Changes in the cross-sectional area and petechiae number were comparable between the groups.

conclusionsNo drug-related adverse reactions occurred. FIT039 efficacy was not determined in this study.

Indexed as

CI, confidence intervalHPV, human papillomavirus

Identifiers

PMID34909725
PMCPMC8659400
OpenAlexW3160959959

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.