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

• ClinicalTrials.gov Identifier: NCT04498403
• Recruitment Status: Terminated
• First Posted: August 4, 2020
• Results First Posted: August 12, 2021
• Last Update Posted: August 12, 2021
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Study Description

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A PHASE 3, MULTICENTER, OPEN-LABEL STUDY OF THE LONG-TERM SAFETY OF CRISABOROLE OINTMENT, 2% IN JAPANESE PEDIATRIC AND ADULT PARTICIPANTS WITH MILD TO MODERATE ATOPIC DERMATITIS
• Actual Study Start Date: September 14, 2020
• Actual Primary Completion Date: December 18, 2020
• Actual Study Completion Date: December 18, 2020

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

Japan

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

Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

  Study Documents (Full-Text)

Documents provided by Pfizer:

Study Protocol  [PDF] May 20, 2020

Statistical Analysis Plan  [PDF] January 7, 2021

More Information

Additional Information:

To obtain contact information for a study center near you, click here. 

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT04498403
• Other Study ID Numbers: C3291027
• First Posted: August 4, 2020
• 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: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
• URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pfizer:

Eczema; Crisaborole

Additional relevant MeSH terms:

Dermatitis, Atopic; Dermatitis; Eczema; Skin Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases