Evidence map›Paper›PMID 36811773›Full record

ArticleDermatology and therapy2023

Impact of Crisaborole on Sleep Outcomes in Pediatric Patients with Mild-to-Moderate Atopic Dermatitis.

Joseph Fowler, Jeffrey Sugarman, Lawrence Sher, Chuanbo Zang, John L Werth, Daniela E Myers, Daniela Graham, Alexander Agyei Marfo, Liza Takiya

3 registry-linked trialsOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Dermatology and therapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 4 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 2 pooled it
1.4field-weighted citation impact, top 19% 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
NCT03356977 phase4completednot on this map

A phase 4, multicenter, open-label safety study of crisaborole ointment 2% in children aged 3 months to less than 24 months with mild to moderate atopic dermatitis

TypeinterventionalSponsorPfizerRan2018 to 2019Enrolled137ConditionsAtopic DermatitisArmsCrisaborole ointment 2%
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 2 syntheses or guidelines pooled it, 5 citations in OpenAlex.

  1. Pooled it
  2. Topical anti-inflammatory treatments for eczema: network meta-analysis.The Cochrane database of systematic reviews · 2024
    Pooled it
  3. Review
  4. 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

9 authors at 4 institutions in 1 country.

Joseph FowlerDermatology Specialists Research LLC and University of Louisville School of Medicine, Louisville, KY, USA.
Jeffrey SugarmanUniversity of California, San Francisco, CA, USA.
Lawrence SherPalos Verdes Medical Group, Rolling Hills Estates, CA, USA.
Chuanbo ZangPfizer Inc., Collegeville, PA, USA.
John L WerthPfizer Inc., Collegeville, PA, USA.
Daniela E MyersPfizer Inc., Collegeville, PA, USA.
Daniela GrahamPfizer Inc., Groton, CT, USA.
Alexander Agyei MarfoPfizer Inc., 235 East 42Nd Street, 235:13/S33, New York, NY, 10017, USA. alexander.a.marfo@pfizer.com.ORCID http://orcid.org/0000-0003-3229-0666
Liza TakiyaPfizer Inc., Collegeville, PA, USA.
Pfizer (United States) · USPalo Verde Hospital · USUniversity of California, San Francisco · USUniversity of Louisville · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionUsing data from three clinical trials, the effect of crisaborole treatment on sleep outcomes for pediatric patients with atopic dermatitis (AD) and their families was examined.

methodsThis analysis comprised patients aged 2 to < 16 years from the double-blind phase 3 CrisADe CORE 1 (NCT02118766) and CORE 2 (NCT02118792) studies, families of patients aged 2 to < 18 years from CORE 1 and CORE 2, and patients aged 3 months to < 2 years from the open-label phase 4 CrisADe CARE 1 study (NCT03356977), all with mild-to-moderate AD who received crisaborole ointment 2% twice daily for 28 days. Sleep outcomes were assessed via the Children's Dermatology Life Quality Index and Dermatitis Family Impact questionnaires in CORE 1 and CORE 2 and the Patient-Oriented Eczema Measure questionnaire in CARE 1.

resultsIn CORE 1 and CORE 2, a significantly lower proportion of crisaborole-treated patients than vehicle-treated patients reported sleep disruption at day 29 (48.5% versus 57.7%, p = 0.001). The proportion of families whose sleep was affected by their child's AD in the preceding week was also significantly lower in the crisaborole group (35.8% versus 43.1%, p = 0.02) at day 29. At day 29 in CARE 1, the proportion of crisaborole-treated patients who experienced ≥ 1 night of disturbed sleep in the previous week decreased by 32.1% from baseline.

conclusionThese results suggest that crisaborole improves sleep outcomes in pediatric patients with mild-to-moderate AD and their families.

Indexed as

Atopic dermatitisCrisaborolePediatricsSleep

Identifiers

PMID36811773
PMCPMC10060611
OpenAlexW4321480289

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.