A Study to Evaluate Long-Term Maintenance Treatment With Once Daily Crisaborole Ointment 2% in Pediatric and Adult Participants With Mild-to-Moderate Atopic Dermatitis

Completed · Phase 3

Conditions studied: Atopic Dermatitis

In brief

This study will evaluate crisaborole therapy once daily (QD) as a long-term topical maintenance therapy for the reduction of flare in responders to crisaborole twice daily (BID) treatment.

Key facts

Study ID

NCT04040192

Run by

Pfizer

People needed

620

Starts

2019-09-12

Expected to finish

2022-01-19

Last updated by the study team

2023-03-08

Who can join

Age: 0 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female
• 3 months of age and older
• Confirmed diagnosis of atopic dermatitis according to Hanifin and Rajka criteria
• Minimum of 5% BSA affected by atopic dermatitis
• ISGA score of Mild (2) or Moderate (3)

You may not qualify if…

• Has any clinically significant medical disorder, condition, or disease (including active or potentially recurrent non AD dermatological conditions and known genetic dermatological conditions that overlap with AD, such as Netherton syndrome).

Where it is running

• First OC Dermatology — Fountain Valley, California, United States
• Center for Dermatology Clinical Research, Inc. — Fremont, California, United States
• Asthma and Allergy Associates, PC — Colorado Springs, Colorado, United States
• Colorado Springs Dermatology Clinic, PC — Colorado Springs, Colorado, United States
• Skin Care Research LLC — Boca Raton, Florida, United States
• Clinical Neuroscience Solutions, Inc — Jacksonville, Florida, United States
• Olympian Clinical Research — Largo, Florida, United States
• Baumann Cosmetic and Research Institute — Miami, Florida, United States
• Clinical Neuroscience Solutions, Inc — Orlando, Florida, United States
• The Indiana Clinical Trials Center, PC — Plainfield, Indiana, United States
• Meridian Clinical Research, LLC — Baton Rouge, Louisiana, United States
• Great Lakes Research Group, Inc. — Bay City, Michigan, United States
• Skin Specialists PC — Omaha, Nebraska, United States
• Ohio Pediatric Research Association, Inc. — Dayton, Ohio, United States
• Lynn Health Science Institute — Oklahoma City, Oklahoma, United States
• Oklahoma State University - Center for Health Sciences — Tulsa, Oklahoma, United States
• Clinical Neuroscience Solutions, Inc. — Memphis, Tennessee, United States
• Innovate Research, LLC — Fort Worth, Texas, United States
• Austin Institute for Clinical Research — Houston, Texas, United States
• Austin Institute for Clinical Research, Inc. — Pflugerville, Texas, United States
• Center for Clinical Studies, LTD. LLP — Webster, Texas, United States
• Jordan Valley Dermatology Center — South Jordan, Utah, United States
• PI-Coor Clinical Research LLC — Burke, Virginia, United States
• Dermatology Specialists of Spokane — Spokane, Washington, United States
• Principle Research Solutions — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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