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Trial record 1 of 1 for:    C3291027
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A Study of the Long-Term Safety of Crisaborole Ointment, 2% in Japanese Pediatric and Adult Participants With Mild to Moderate Atopic Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04498403
Recruitment Status : Terminated (Terminated (This decision was made for business reasons only and is not related to any safety concerns regarding crisaborole.))
First Posted : August 4, 2020
Results First Posted : August 12, 2021
Last Update Posted : August 12, 2021
Information provided by (Responsible Party):

Brief Summary:
This study is a Phase 3, multicenter, open-label, long-term safety extension study of Studies C3291032 and C3291031 in Japanese pediatric and adult participants with mild to moderate Atopic Dermatitis (AD).

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Crisaborole 2% Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : September 14, 2020
Actual Primary Completion Date : December 18, 2020
Actual Study Completion Date : December 18, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
Drug Information available for: Crisaborole

Arm Intervention/treatment
Experimental: Crisaborole 2%
Crisaborole 2% ointment applied twice daily (BID)
Drug: Crisaborole 2%
Crisaborole 2% ointment

Primary Outcome Measures :
  1. Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to 28 days after last dose of study drug (maximum up to 12 weeks) ]
    An adverse events (AE) is any untoward medical occurrence in clinical investigation participant administered a product or medical device; event need not necessarily to had a causal relationship with treatment or usage. SAEs: an AE resulting in any of following outcomes/deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs are events between first dose of study drug and up to 28 days after last dose of study drug, that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   7 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female participants;
  • Who were patients with mild to moderate AD aged 2 years old or older and met eligibility criteria for study C3291032 at the time when entering Study C3291032, and completed treatment period in Study C3291032 without safety issues. Or
  • Who were patients with mild to moderate AD aged 1 months to <24 months and met eligibility criteria for Study C3291031 at the time when entering Study C3291031, and completed treatment period in Study C3291031 without safety issues

Exclusion Criteria:

  • Has other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04498403

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Shirao Clinic of Pediatrics and Pediatric Allergy
Hiroshima-shi, Hiroshima, Japan, 734-0023
Chitose dermatology and plastic surgery clinic
Chitose Shi, Hokkaido, Japan, 066-0021
Takagi Dermatological Clinic
Obihiro, Hokkaido, Japan, 080-0013
Yoshimura Child Clinic
Akashi-City, Hyōgo, Japan, 674-0068
Iryouhoujinshadan Yamayurikai Tsujino. Kodomo Clinic
Kobe-City, Hyōgo, Japan, 658-0082
Noguchi Dermatology Clinic
Kamimashiki-gun, Kumamoto, Japan, 861-3101
Yoshioka Dermatology Clinic
Neyagawa, Osaka, Japan, 572-0838
Mildix Skin Clinic
Adachi-ku, Tokyo, Japan, 120-0034
Yoga Allergy Clinic
Setagaya-ku, Tokyo, Japan, 158-0097
Sugamo Kobayashi Derma Clinic
Toshima-Ku, Tokyo, Japan, 170-0002
Hoshikuma Dermatology・Allergy Clinic
Fukuoka, Japan, 814-0171
Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer
  Study Documents (Full-Text)

Documents provided by Pfizer:
Study Protocol  [PDF] May 20, 2020
Statistical Analysis Plan  [PDF] January 7, 2021

Additional Information:
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Responsible Party: Pfizer Identifier: NCT04498403    
Other Study ID Numbers: C3291027
First Posted: August 4, 2020    Key Record Dates
Results First Posted: August 12, 2021
Last Update Posted: August 12, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at:

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
Additional relevant MeSH terms:
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Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Immune System Diseases