Evidence map›Paper›PMID 35522900›Full record

Trial reportClinical and translational medicine2022

Topical niclosamide (ATx201) reduces Staphylococcus aureus colonization and increases Shannon diversity of the skin microbiome in atopic dermatitis patients in a randomized, double-blind, placebo-controlled Phase 2 trial.

Anne Weiss, Emilie Delavenne, Carina Matias, Heimo Lagler, Daniel Simon, Ping Li, Jon U Hansen, Teresa Pires Dos Santos, Bimal Jana, Petra Priemel and 27 more

Open access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Clinical and translational medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed
9.1field-weighted citation impact, top 2% 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

25 citing papers in PubMed, 45 citations in OpenAlex.

  1. Trial
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  6. Atopic Dermatitis-like mouse model using early inoculation of patient-derivedJID innovations : skin science from molecules to population health · 2026
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  14. Adding Fuel to the Fire? The Skin Microbiome in Atopic Dermatitis.The Journal of investigative dermatology · 2024
    Review
  15. Skin microbiota: pathogenic roles and implications in atopic dermatitis.Frontiers in cellular and infection microbiology · 2024
    Review
  16. Review
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  19. Challenges and Future Trends in Atopic Dermatitis.International journal of molecular sciences · 2023
    Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

37 authors at 11 institutions in 5 countries.

Anne WeissUNION Therapeutics, Hellerup, Denmark.
Emilie DelavenneUNION Therapeutics, Hellerup, Denmark.
Carina MatiasUNION Therapeutics, Hellerup, Denmark.
Heimo LaglerDepartment of Medicine 1, Division of Infectious Diseases and Tropical Medicine, Medical University of Vienna, Wien, Austria.
Daniel SimonUNION Therapeutics, Hellerup, Denmark.
Ping LiUNION Therapeutics, Hellerup, Denmark.
Jon U HansenDepartment of Bacteria, Parasites and Fungi, Statens Serum Institut, Copenhagen, Denmark.
Teresa Pires Dos SantosDepartment of Veterinary and Animal Sciences, University of Copenhagen, Frederiksberg C, Denmark.
Bimal JanaDepartment of Veterinary and Animal Sciences, University of Copenhagen, Frederiksberg C, Denmark.
Petra PriemelDepartment of Pharmacy, University of Copenhagen, Copenhagen, Denmark.
Christine BangertDepartment of Dermatology, Medical University of Vienna, Wien, Austria.
Martin BauerDepartment of Clinical Pharmacology, Medical University of Vienna, Wien, Austria.
Sabine EberlDepartment of Clinical Pharmacology, Medical University of Vienna, Wien, Austria.
Alina Nussbaumer-PröllDepartment of Clinical Pharmacology, Medical University of Vienna, Wien, Austria.
Zoe Anne ÖsterreicherDepartment of Clinical Pharmacology, Medical University of Vienna, Wien, Austria.
Peter MatznellerDepartment of Clinical Pharmacology, Medical University of Vienna, Wien, Austria.
Tamara QuintDepartment of Dermatology, Medical University of Vienna, Wien, Austria.
Maria WeberDepartment of Clinical Pharmacology, Medical University of Vienna, Wien, Austria.
Hanne Mørck NielsenDepartment of Pharmacy, University of Copenhagen, Copenhagen, Denmark.
Thomas RadesDepartment of Pharmacy, University of Copenhagen, Copenhagen, Denmark.
Helle Krogh JohansenDepartment of Clinical Microbiology, Rigshospitalet, Copenhagen, Denmark.
Henrik WesthHvidovre Hospital, Hvidovre, Denmark.
Wooseong KimWarren Alpert Medical School of Brown University, Division of Infectious Diseases, Rhode Island Hospital, Providence, Rhode Island, USA.
Eleftherios MylonakisWarren Alpert Medical School of Brown University, Division of Infectious Diseases, Rhode Island Hospital, Providence, Rhode Island, USA.
Christian FriisDepartment of Veterinary and Animal Sciences, University of Copenhagen, Frederiksberg C, Denmark.
Luca GuardabassiDepartment of Veterinary and Animal Sciences, University of Copenhagen, Frederiksberg C, Denmark.
John PaceUNION Therapeutics, Hellerup, Denmark.
Carina Vingsbo LundbergDepartment of Bacteria, Parasites and Fungi, Statens Serum Institut, Copenhagen, Denmark.
Fatima M'ZaliUniversity of Bordeaux, Bordeaux Cede.
Pascal ButtyCEVA Santé Animale, Libourne, France.
Nikolaj SørensenClinical Microbiomics, Copenhagen, Denmark.
Henrik Bjørn NielsenClinical Microbiomics, Copenhagen, Denmark.
Rasmus Toft-KehlerUNION Therapeutics, Hellerup, Denmark.
Emma Guttman-YasskyIcahn School of Medicine at Mount Sinai, New York, New York, USA.
Georg StinglDepartment of Dermatology, Medical University of Vienna, Wien, Austria.
Markus ZeitlingerDepartment of Clinical Pharmacology, Medical University of Vienna, Wien, Austria.
Morten SommerUNION Therapeutics, Hellerup, Denmark.ORCID 0000-0003-4005-5674
Medical University of Vienna · ATUniversity of Copenhagen · DKZero to Three · USBrown University · USNovo Nordisk Foundation · DKStatens Serum Institut · DKClinical Microbiomics (Denmark) · DKHvidovre Hospital · DKIcahn School of Medicine at Mount Sinai · USNew York University Shanghai · CNUniversité de Bordeaux · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn patients with atopic dermatitis (AD), Staphylococcus aureus frequently colonizes lesions and is hypothesized to be linked to disease severity and progression. Treatments that reduce S. aureus colonization without significantly affecting the skin commensal microbiota are needed. METHODS AND

findingsIn this study, we tested ATx201 (niclosamide), a small molecule, on its efficacy to reduce S. aureus and propensity to evolve resistance in vitro. Various cutaneous formulations were then tested in a superficial skin infection model. Finally, a Phase 2 randomized, double-blind and placebo-controlled trial was performed to investigate the impact of ATx201 OINTMENT 2% on S. aureus colonization and skin microbiome composition in patients with mild-to-severe AD (EudraCT:2016-003501-33). ATx201 has a narrow minimal inhibitory concentration distribution (.125-.5 μg/ml) consistent with its mode of action - targeting the proton motive force effectively stopping cell growth. In murine models, ATx201 can effectively treat superficial skin infections of methicillin-resistant S. aureus. In a Phase 2 trial in patients with mild-to-severe AD (N = 36), twice-daily treatment with ATx201 OINTMENT 2% effectively reduces S. aureus colonization in quantitative colony forming unit (CFU) analysis (primary endpoint: 94.4% active vs. 38.9% vehicle success rate, p = .0016) and increases the Shannon diversity of the skin microbiome at day 7 significantly compared to vehicle.

conclusionThese results suggest that ATx201 could become a new treatment modality as a decolonizing agent.

Indexed as

Dermatitis, AtopicMethicillin-Resistant Staphylococcus aureusMicrobiotaStaphylococcal InfectionsAnimalsAnti-Bacterial AgentsHumansMiceNiclosamideOintmentsStaphylococcus aureusAnti-Bacterial AgentsNiclosamideOintmentsbench-to-bedsidedermatologymicrobiomesmall molecule

Identifiers

PMID35522900
PMCPMC9076020
OpenAlexW4229007034

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Registered trials

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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.