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

Phase 3

Terminated

• Conditions: Atopic Dermatitis
• Interventions: Drug: Crisaborole 2%

• Registration Number: NCT04498403
• Lead Sponsor: Pfizer

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-31
• Study First Submitted QC: 2020-07-31
• Study First Posted: 2020-08-04
• Study Start: 2020-09-14
• Primary Completion: 2020-12-18
• Study Completion: 2020-12-18
• Results First Submitted: 2021-06-14
• Status Verified: 2021-07
• Results First Submitted QC: 2021-07-20
• Last Update Submitted: 2021-07-20
• Results First Posted: 2021-08-12
• Last Update Posted: 2021-08-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Crisaborole 2%	Crisaborole 2%	Crisaborole 2% ointment applied twice daily (BID)

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	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.

Trial Locations

Locations (11)

Mildix Skin Clinic; 🇯🇵 Adachi-ku, Tokyo, Japan

Sugamo Kobayashi Derma Clinic; 🇯🇵 Toshima-Ku, Tokyo, Japan

Takagi Dermatological Clinic; 🇯🇵 Obihiro, Hokkaido, Japan

Iryouhoujinshadan Yamayurikai Tsujino. Kodomo Clinic; 🇯🇵 Kobe-City, Hyōgo, Japan

Shirao Clinic of Pediatrics and Pediatric Allergy; 🇯🇵 Hiroshima-shi, Hiroshima, Japan

Noguchi Dermatology Clinic; 🇯🇵 Kamimashiki-gun, Kumamoto, Japan

Yoga Allergy Clinic; 🇯🇵 Setagaya-ku, Tokyo, Japan

Hoshikuma Dermatology・Allergy Clinic; 🇯🇵 Fukuoka, Japan

Yoshimura Child Clinic; 🇯🇵 Akashi-City, Hyōgo, Japan

Chitose dermatology and plastic surgery clinic; 🇯🇵 Chitose Shi, Hokkaido, Japan

Yoshioka Dermatology Clinic; 🇯🇵 Neyagawa, Osaka, Japan