Evidence map›Paper›PMID 38748345›Full record

ArticleDermatology and therapy2024

Efficacy and Safety of Crisaborole Ointment 2% in Chinese Patients Aged ≥ 2 Years with Mild to Moderate Atopic Dermatitis.

Lin Ma, Xiaohua Tao, Sujun Liu, Hao Cheng, Ruihua Fang, Yan Zhao, Amy Cha, Gerardo A Encinas, Yangmei Zhou, Yujie Deng and 1 more

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Dermatology and therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04360187 (A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE BLIND, VEHICLE CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF CRISABOROLE OINTMENT, 2% IN CHINESE AND JAPANESE PEDIATRIC AND ADULT SUBJECTS), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

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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.

NCT04360187 phase3completednot on this map

A phase 3, multicenter, randomized, double blind, vehicle controlled study of the efficacy and safety of crisaborole ointment, 2% in chinese and japanese pediatric and adult subjects (ages 2 years and older) with mild to moderate atopic dermatitis

TypeinterventionalSponsorPfizerRan2020 to 2021Enrolled391ConditionsAtopic DermatitisArmsCrisaborole Ointment, Crisaborole Placebo Vehicle
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Review
  2. Article
  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

11 authors.

Lin MaDepartment of Dermatology, Beijing Children's Hospital, National Center for Children's Health, Capital Medical University, Beijing, China.
Xiaohua TaoDepartment of Dermatology, Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang, China.
Sujun LiuDepartment of Dermatology, Hangzhou Third People's Hospital, Hangzhou, Zhejiang, China.
Hao ChengDepartment of Dermatology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, China.
Ruihua FangDepartment of Dermatology, Guangzhou First People's Hospital, Guangzhou, Guangdong, China.
Yan ZhaoDepartment of Dermatology, Peking University People's Hospital, Beijing, 100044, China.
Amy ChaPfizer Inc., New York, NY, USA.
Gerardo A EncinasPfizer SA DE CV, Mexico City, Mexico.
Yangmei ZhouClinical Development, Pfizer R&D China, Shanghai, China.
Yujie DengPfizer Beijing, Beijing, China.
Jianzhong ZhangDepartment of Dermatology, Peking University People's Hospital, Beijing, 100044, China. rmzjz@126.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionAtopic dermatitis (AD) is a chronic immuno-inflammatory skin disease. Crisaborole ointment, 2%, is a nonsteroidal phosphodiesterase 4 inhibitor approved for the treatment of mild to moderate AD. This post hoc analysis assesses the efficacy and safety of crisaborole in Chinese patients aged ≥ 2 years with mild to moderate AD.

methodsWe evaluated the efficacy and safety of crisaborole in Chinese patients from the vehicle-controlled, phase 3 CrisADe CLEAR study. Patients were randomly assigned 2:1 to receive crisaborole or vehicle twice daily, respectively, for 28 days. The primary endpoint was percent change from baseline in Eczema Area and Severity Index (EASI) total score at day 29. Key secondary endpoints were improvement in Investigator's Static Global Assessment (ISGA), ISGA success, and change from baseline in weekly average Peak Pruritus Numerical Rating Scale (PP-NRS) score. Adverse events were documented.

resultsOf 391 patients in the overall study, 237 were from China, 157 assigned to crisaborole and 80 assigned to vehicle. A greater reduction in percent change from baseline in EASI total score at day 29 was shown in the crisaborole vs. vehicle group (least squares mean [LSM]: -66.34 [95% (confidence interval) CI -71.55 to -61.12] vs. -50.18 [95% CI -58.02 to -42.34]). Response rates for achievement of ISGA improvement (43.2% [95% CI 35.4-51.1] vs. 33.4% [95% CI 22.5-44.2]) and ISGA success (31.7% [95% CI 24.3-39.0] vs. 21.5% [95% CI 12.1-30.9]) at day 29 were higher in the crisaborole vs. vehicle group. A greater reduction in change from baseline in weekly average PP-NRS score at week 4 was observed in the crisaborole vs. vehicle group (LSM: -1.98 [95% CI -2.34 to -1.62] vs. -1.08 [95% CI -1.63 to -0.53]). No new safety signals were observed.

conclusionCrisaborole was effective and well tolerated in Chinese patients aged ≥ 2 years with mild to moderate AD.

trial registrationClinicalTrials.gov, NCT04360187.

Indexed as

Atopic dermatitisChinese patientsCrisaboroleEczema Area and Severity IndexInfantPhosphodiesterase 4 inhibitors

Identifiers

PMID38748345
PMCPMC11116293

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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.