Evidence map›Paper›PMID 31264114›Full record

Trial reportAmerican journal of clinical dermatology2019

Efficacy and Safety of Crisaborole Ointment, 2%, for the Treatment of Mild-to-Moderate Atopic Dermatitis Across Racial and Ethnic Groups.

Valerie D Callender, Andrew F Alexis, Linda F Stein Gold, Mark G Lebwohl, Amy S Paller, Seemal R Desai, Huaming Tan, William C Ports, Michael A Zielinski, Anna M Tallman

Open access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in American journal of clinical dermatology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
4.0field-weighted citation impact, top 7% 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

18 citing papers in PubMed, 40 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. Review
  5. E2F1-induced upregulation ofHistology and histopathology · 2025
    Article
  6. Article
  7. Review
  8. Special Considerations of Atopic Dermatitis in Skin of Color.Advances in experimental medicine and biology · 2024
    Review
  9. Article
  10. Review
  11. Atopic Dermatitis Across Shades of Skin.American journal of clinical dermatology · 2023
    Review
  12. Article
  13. Chronic itch in African Americans: an unmet need.Archives of dermatological research · 2022
    Review
  14. Article
  15. Article
  16. The Role of PDE8 in T Cell Recruitment and Function in Inflammation.Frontiers in cell and developmental biology · 2021
    Review
  17. The Journal of clinical and aesthetic dermatology · 2020
    Article
  18. What is new in dermatotherapy?Indian journal of dermatology, venereology and leprology
    Review
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 7 institutions in 1 country.

Valerie D CallenderHoward University College of Medicine, Washington, DC, USA. drcallender@CallenderSkin.com.ORCID http://orcid.org/0000-0003-1297-5270
Andrew F AlexisMount Sinai St. Luke's and Mount Sinai West, New York, NY, USA.
Linda F Stein GoldHenry Ford Health System, Detroit, MI, USA.
Mark G LebwohlIcahn School of Medicine at Mount Sinai, New York, NY, USA.
Amy S PallerNorthwestern University Feinberg School of Medicine, Chicago, IL, USA.
Seemal R DesaiUniversity of Texas Southwestern Medical Center, Dallas, TX, USA.
Huaming TanPfizer Inc., Groton, CT, USA.
William C PortsPfizer Inc., Groton, CT, USA.
Michael A ZielinskiPfizer Inc., Collegeville, PA, USA.
Anna M TallmanPfizer Inc., New York, NY, USA.
Pfizer (United States) · USHenry Ford Health System · USHoward University · USIcahn School of Medicine at Mount Sinai · USMount Sinai Hospital · USNorthwestern University · USThe University of Texas Southwestern Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAtopic dermatitis is highly prevalent in black/African American, Asian, and Hispanic patients, making assessment of these populations in clinical trials important. Crisaborole ointment, 2%, is a nonsteroidal phosphodiesterase 4 inhibitor for the treatment of mild-to-moderate atopic dermatitis. In two pivotal phase III clinical trials in patients aged ≥ 2 years, crisaborole was superior to vehicle in reducing global disease severity. The most common treatment-related adverse event was application site pain.

objectiveThe objective of this study was to investigate the efficacy and safety of crisaborole according to patient race and ethnicity.

methodsA pooled post hoc analysis by race and ethnicity of the two pivotal trials and a safety extension trial was performed. Race included white or nonwhite (encompassing Asian/native Hawaiian/other Pacific Islander, black/African American, and other/American Indian/Alaskan native); ethnicity included Hispanic/Latino or not Hispanic/Latino.

resultsIn white, nonwhite, Hispanic/Latino, and not Hispanic/Latino groups at day 29, more crisaborole- than vehicle-treated patients achieved improvements in global disease severity [Investigator's Static Global Assessment of clear/almost clear with a ≥ 2-grade improvement (white: 33.5% vs. 22.3%, nominal p < 0.001; nonwhite: 30.0% vs. 21.3%, nominal p < 0.05; Hispanic/Latino: 35.4% vs. 18.2%, nominal p < 0.01; not Hispanic/Latino: 31.3% vs. 22.8%, nominal p < 0.01)]. Crisaborole treatment also improved atopic dermatitis signs/symptoms and quality of life. Frequency of crisaborole-related adverse events was 7.1-8.5% in the pivotal trials.

conclusionAcross races and ethnicities, crisaborole demonstrated efficacy for the treatment of mild-to-moderate atopic dermatitis, with a low frequency of treatment-related adverse events.

Indexed as

Health Status DisparitiesAdministration, CutaneousAdolescentAdultAgedBoron CompoundsBridged Bicyclo Compounds, HeterocyclicChildChild, PreschoolDermatitis, AtopicDermatologic AgentsEthnicityFemaleHumansMaleMiddle AgedBoron CompoundsBridged Bicyclo Compounds, HeterocycliccrisaboroleDermatologic AgentsOintments

Identifiers

PMID31264114
PMCPMC6764931
OpenAlexW2954160032

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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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.