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

Atopic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04498403
• Other study ID #: C3291027
• Status: Terminated
• Phase: Phase 3
• Start date: September 14, 2020
• Est. completion date: December 18, 2020

Study information

• Verified date: July 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: December 18, 2020
• Est. primary completion date: December 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Months and older

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Crisaborole 2%
Crisaborole 2% ointment

Locations

Country	Name	City	State
Japan	Mildix Skin Clinic	Adachi-ku	Tokyo
Japan	Yoshimura Child Clinic	Akashi-City	Hyogo
Japan	Chitose dermatology and plastic surgery clinic	Chitose Shi	Hokkaido
Japan	Hoshikuma Dermatology·Allergy Clinic	Fukuoka
Japan	Shirao Clinic of Pediatrics and Pediatric Allergy	Hiroshima-shi	Hiroshima
Japan	Noguchi Dermatology Clinic	Kamimashiki-gun	Kumamoto
Japan	Iryouhoujinshadan Yamayurikai Tsujino. Kodomo Clinic	Kobe-City	Hyogo
Japan	Yoshioka Dermatology Clinic	Neyagawa	Osaka
Japan	Takagi Dermatological Clinic	Obihiro	Hokkaido
Japan	Yoga Allergy Clinic	Setagaya-ku	Tokyo
Japan	Sugamo Kobayashi Derma Clinic	Toshima-Ku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)

External Links

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