Evidence map›Paper›PMID 34041788›Full record

Trial reportThe Journal of dermatology2021

A phase III, 52-week, open-label study to evaluate the safety and efficacy of 5% sofpironium bromide (BBI-4000) gel in Japanese patients with primary axillary hyperhidrosis.

Tomoko Fujimoto, Yoichiro Abe, Masaru Igarashi, Akiko Ishikoh, Tokuya Omi, Hiroki Kanda, Hiroto Kitahara, Miwako Kinoshita, Ichiro Nakasu, Naoko Hattori and 16 more

Open access · hybridAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Journal of dermatology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
1.7field-weighted citation impact, top 16% 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

8 citing papers in PubMed, 17 citations in OpenAlex.

  1. Soft drugs: design principles and topical applications.Nature reviews. Drug discovery · 2026
    Review
  2. Review
  3. Review
  4. Review
  5. Review
  6. Review
  7. Treatment of Hyperhidrosis: An Update.American journal of clinical dermatology · 2022
    Review
  8. Observational
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

26 authors at 6 institutions in 1 country.

Tomoko FujimotoIkebukuro Nishiguchi Fukurou Dermatology Clinic, Tokyo, Japan.
Yoichiro AbeDepartment of Pain Clinic, NTT Medical Center Tokyo, Tokyo, Japan.
Masaru IgarashiIgarashi Dermatology Clinic, Tokyo, Japan.
Akiko IshikohKaminoge Hifuka Clinic, Tokyo, Japan.
Tokuya OmiDepartment of Dermatology, Queen's Square Medical Center, Kanagawa, Japan.
Hiroki KandaMita Dermatology Clinic, Tokyo, Japan.
Hiroto KitaharaKitahara Dermatology Clinic, Tokyo, Japan.
Miwako KinoshitaKinoshita Dermatology Clinic, Tokyo, Japan.
Ichiro NakasuNemunoki Dermatology Clinic, Kanagawa, Japan.
Naoko HattoriNaoko Dermatology Clinic, Tokyo, Japan.
Yuki HoriuchiAkihabara Skin Clinic, Tokyo, Japan.
Ryuji MaruyamaMaruyama Dermatology Clinic, Tokyo, Japan.
Haruko MizutaniMizutani Dermatology Clinic, Tokyo, Japan.
Yoshiyuki MurakamiMildix Skin Clinic, Tokyo, Japan.
Chiharu WatanabeChiharu Dermatology Clinic, Saitama, Japan.
Akihiro KumeDermatology and Ophthalmology Kume Clinic, Osaka, Japan.
Takaaki HanafusaSenri-Chuo Hanafusa Dermatology Clinic, Osaka, Japan.
Masamitsu HamaguchiHamaguchi Clinic, Osaka, Japan.
Akira YoshiokaYoshioka Dermatology Clinic, Osaka, Japan.
Yuriko EgamiEkihigashi Dermatology and Allergology Clinic, Fukuoka, Japan.
Keizo MatsuoMatsuo Clinic, Fukuoka, Japan.
Tomoko MatsudaTomoko Matsuda Dermatological Clinic, Fukuoka, Japan.
Motoki AkamatsuKaken Pharmaceutical Co., Ltd., Tokyo, Japan.
Toshiyuki YorozuyaKaken Pharmaceutical Co., Ltd., Tokyo, Japan.
Shinichi TakayamaKaken Pharmaceutical Co., Ltd., Tokyo, Japan.
Hiroo YokozekiDepartment of Dermatology, Tokyo Medical and Dental University, Tokyo, Japan.ORCID https://orcid.org/0000-0002-5773-9485
Kaken Pharmaceutical (Japan) · JPOno Clinic · JPMita Hospital · JPNTT Medical Center · JPOsaka Nishi Clinic · JPTokyo Medical and Dental University · JP

Funding

Kaken Pharmaceutical Co., Ltd.
6 · The paper itself

Abstract

A long-term study was conducted in Japanese patients with primary axillary hyperhidrosis who completed the preceding 6-week phase III, confirmatory study of 5% sofpironium bromide gel (hereinafter referred to as sofpironium) to evaluate the safety and efficacy of 52-week treatment with sofpironium. In the long-term study, 185 patients who completed the confirmatory study (94 and 91 patients in the vehicle and sofpironium groups, respectively) started to receive sofpironium (switching and extension groups, respectively), and all these patients were included in both the full analysis set (FAS) and the safety analysis set (SAF). In the FAS, there were more females than males (73.0% vs. 27.0%), and median age was 38.0 years. A total of 161 patients (86 and 75 patients in the switching and extension groups, respectively) completed the study at week 52. The proportions of patients with hyperhidrosis disease severity score of 1 or 2 and a 50% or more reduction in total gravimetric weight of sweat were 57.4% in the switching group and 58.2% in the extension group at week 52. The proportions of patients who achieved this efficacy end-point in the long-term study were similar to that (53.9%) in the sofpironium group in the confirmatory study. In the SAF, the incidences of adverse events (AEs) were 80.9% in the switching group and 83.5% in the extension group, and the incidences of adverse drug reactions were 39.4% and 45.1%, respectively. AEs that occurred in at least 20% of patients in both treatment groups were application site dermatitis (25.5% and 33.0%, respectively) and nasopharyngitis (31.9% and 23.1%, respectively). Reported AEs were generally mild, and there were no deaths. Serious AEs occurred in three patients, but none were considered related to the study drug. In this study, the efficacy of sofpironium was maintained during 52-week treatment, and no new safety risk was observed.

Indexed as

BromidesHyperhidrosisAdultDouble-Blind MethodFemaleHumansJapanMaleTreatment OutcomeBromides52-week studyBBI-4000phase III studyprimary axillary hyperhidrosissofpironium bromide gel

Identifiers

PMID34041788
PMCPMC8453842
OpenAlexW3165631791

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.