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

NCT04498403 | Terminated Phase 3 Results

• 1 other identifier: C3291027
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 11

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).

Conditions

Atopic Dermatitis

Keywords

Eczema; Crisaborole

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

  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.

  Baseline up to 28 days after last dose of study drug (maximum up to 12 weeks)

Study Arms (1)

Crisaborole 2%

EXPERIMENTAL

Crisaborole 2% ointment applied twice daily (BID)

Drug: Crisaborole 2%

Interventions

Crisaborole 2% DRUG

Crisaborole 2% ointment

Crisaborole 2%

Eligibility Criteria

• Age: 7 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (11)

Shirao Clinic of Pediatrics and Pediatric Allergy

Hiroshima, Hiroshima, 734-0023, Japan

Location

Chitose dermatology and plastic surgery clinic

Chitose Shi, Hokkaido, 066-0021, Japan

Location

Takagi Dermatological Clinic

Obihiro, Hokkaido, 080-0013, Japan

Location

Yoshimura Child Clinic

Akashi, Hyōgo, 674-0068, Japan

Location

Iryouhoujinshadan Yamayurikai Tsujino. Kodomo Clinic

Kobe, Hyōgo, 658-0082, Japan

Location

Noguchi Dermatology Clinic

Kamimashiki-gun, Kumamoto, 861-3101, Japan

Location

Yoshioka Dermatology Clinic

Neyagawa, Osaka, 572-0838, Japan

Location

Mildix Skin Clinic

Adachi-ku, Tokyo, 120-0034, Japan

Location

Yoga Allergy Clinic

Setagaya-ku, Tokyo, 158-0097, Japan

Location

Sugamo Kobayashi Derma Clinic

Toshima-Ku, Tokyo, 170-0002, Japan

Location

Hoshikuma Dermatology・Allergy Clinic

Fukuoka, 814-0171, Japan

Location

Related Links

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

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Limitations and Caveats

Participants were planned to be followed up to Week 56, however due to early termination of the study, participants were followed up to only Week 12.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2020
• First Posted: August 4, 2020
• Study Start: September 14, 2020
• Primary Completion: December 18, 2020
• Study Completion: December 18, 2020
• Last Updated: August 12, 2021
• Results First Posted: August 12, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share

Locations

JP (11)