Evidence map›Paper›PMID 32981097›Full record

Trial reportPediatric dermatology2020

Improvement in disease severity and pruritus outcomes with crisaborole ointment, 2%, by baseline atopic dermatitis severity in children and adolescents with mild-to-moderate atopic dermatitis.

Lawrence F Eichenfield, Gil Yosipovitch, Linda F Stein Gold, Mizuho Kalabis, Chuanbo Zang, Bonnie Vlahos, Paul Sanders, Daniela E Myers, Andrew G Bushmakin, Joseph C Cappelleri and 2 more

2 registry-linked trialsOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Pediatric dermatology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
0.8field-weighted citation impact, top 24% 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.

NCT02118766 phase3completednot on this map

A Multicenter, Randomized, Double-Blind, Vehicle-Controlled Study of the Safety and Efficacy of AN2728 Topical Ointment, 2% in Children, Adolescents, and Adults (Ages 2 Years and Older) With Atopic Dermatitis

TypeinterventionalSponsorPfizerRan2014 to 2015Enrolled763ConditionsDermatitis, AtopicArmsAN2728 Topical Ointment, 2%, Matching vehicle control
NCT02118792 phase3completednot on this map

A Multicenter, Randomized, Double-Blind, Vehicle-Controlled Study of the Safety and Efficacy of AN2728 Topical Ointment, 2% in Children, Adolescents, and Adults (Ages 2 Years and Older) With Atopic Dermatitis

TypeinterventionalSponsorPfizerRan2014 to 2015Enrolled764ConditionsDermatitis, AtopicArmsAN2728 Topical Ointment, 2%, Matching vehicle control
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 12 citations in OpenAlex.

  1. Topical anti-inflammatory treatments for eczema: network meta-analysis.The Cochrane database of systematic reviews · 2024
    Pooled it
  2. Trial
  3. Trial
  4. Review
  5. Review
  6. Review
  7. Review
  8. Treatment Options for Troublesome Itch.Pharmaceuticals (Basel, Switzerland) · 2022
    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

12 authors at 6 institutions in 2 countries.

Lawrence F EichenfieldRady Children's Hospital, UC San Diego School of Medicine, San Diego, California, USA.
Gil YosipovitchMiami Itch Center, Miller School of Medicine, University of Miami, Miami, Florida, USA.
Linda F Stein GoldHenry Ford Health System, Detroit, Michigan, USA.
Mizuho KalabisPfizer Inc, Collegeville, Pennsylvania, USA.
Chuanbo ZangPfizer Inc, Collegeville, Pennsylvania, USA.
Bonnie VlahosPfizer Inc, Collegeville, Pennsylvania, USA.
Paul SandersPfizer R&D UK Ltd, Tadworth, UK.
Daniela E MyersPfizer Inc, Collegeville, Pennsylvania, USA.
Andrew G BushmakinPfizer Inc, Groton, Connecticut, USA.
Joseph C CappelleriPfizer Inc, Groton, Connecticut, USA.
Melissa OlivadotiPfizer Inc, Collegeville, Pennsylvania, USA.
Amy S PallerNorthwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
Pfizer (United States) · USHenry Ford Health System · USNorthwestern University · USPfizer (United Kingdom) · GBRady Children's Hospital-San Diego · USUniversity of Miami · US

Funding

Pfizer
6 · The paper itself

Abstract

BACKGROUND/

objectivesCrisaborole ointment, 2%, is a nonsteroidal phosphodiesterase 4 inhibitor for the treatment of mild-to-moderate atopic dermatitis (AD). This pooled post hoc analysis of two phase 3 trials (NCT02118766, NCT02118792) assessed improvement and time to improvement in Investigator's Static Global Assessment (ISGA) and Severity of Pruritus Scale (SPS) outcomes in pediatric patients with mild-to-moderate AD.

methodsPatients aged ≥2 years were randomly assigned 2:1 to receive twice-daily crisaborole or vehicle for 28 days. Patients aged 2-17 years were pooled for this analysis. Proportions of patients and time to achieving ISGA success (clear [0] or almost clear [1] with ≥2-grade improvement from baseline), ISGA clear/almost clear, ≥1-grade improvement in ISGA, SPS success (SPS score ≤1 with ≥1-grade improvement), or ≥1-grade improvement in SPS score were analyzed and stratified by baseline ISGA.

resultsAt first postbaseline assessment (day 8), significantly higher proportions of crisaborole- than vehicle-treated patients achieved ISGA success, ISGA clear/almost clear, ≥1-grade ISGA improvement, SPS success, or ≥1-grade improvement in SPS regardless of baseline ISGA. Differences were significantly greater over time for all outcomes for patients with moderate baseline ISGA and numerically greater for those with mild baseline ISGA. Median times to ISGA and SPS outcomes were shorter for crisaborole versus vehicle.

conclusionImprovement in ISGA and SPS outcomes were observed with crisaborole in pediatric patients with mild-to-moderate baseline AD.

Indexed as

Dermatitis, AtopicAdolescentBoron CompoundsBridged Bicyclo Compounds, HeterocyclicChildChild, PreschoolDouble-Blind MethodHumansOintmentsPruritusSeverity of Illness IndexTreatment OutcomeBoron CompoundsBridged Bicyclo Compounds, HeterocycliccrisaboroleOintmentsatopic dermatitispruritustherapy-topical

Identifiers

PMID32981097
PMCPMC7756882
OpenAlexW3087852497

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

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.