A Study of Crisaborole Ointment 2% in Children Aged 3-24 Months With Mild to Moderate Atopic Dermatitis

Completed · Phase 4

Conditions studied: Atopic Dermatitis

In brief

This 4-week study will evaluate the safety, pharmacokinetics (PK), and efficacy of crisaborole ointment 2%, applied twice daily (BID) in subjects who are 3 months to less than 24 months of age with mild-to-moderate AD.

Key facts

Study ID

NCT03356977

Run by

Pfizer

People needed

137

Starts

2018-01-16

Expected to finish

2019-04-12

Last updated by the study team

2019-10-10

Who can join

Age: 0 and older, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Aged ≥ 3 months at the screening visit to < 24 months on baseline/Day 1, diagnosed with AD

You may not qualify if…

• Subjects with any clinically significant dermatological condition or disease (including active or potentially recurrent non-AD dermatological conditions that overlap with AD such as Netherton Syndrome)

Where it is running

• Burke Pharmaceutical Research — Hot Springs, Arkansas, United States
• Rady Children's Hospital - San Diego/University of California, San Diego — San Diego, California, United States
• Rady Children's Hospital — San Diego, California, United States
• University of California, San Francisco — San Francisco, California, United States
• IMMUNOe Research Centers — Thornton, Colorado, United States
• Baumann Cosmetic and Research Institute — Miami, Florida, United States
• DS Research — Louisville, Kentucky, United States
• Craig A. Spiegel, M.D. — Bridgeton, Missouri, United States
• Skin Specialists, PC — Omaha, Nebraska, United States
• Ohio Pediatric Research Association, Inc. — Dayton, Ohio, United States
• Oklahoma State University - Center for Health Sciences — Tulsa, Oklahoma, United States
• Oregon Health & Science University — Portland, Oregon, United States
• Penn State Hershey Medical Center — Hershey, Pennsylvania, United States
• DermResearch, Inc. — Austin, Texas, United States
• Texas Dermatology and Laser Specialists — San Antonio, Texas, United States
• Tanner Clinic — Layton, Utah, United States
• Jordan Valley Dermatology Center — West Jordan, Utah, United States
• Timber Lane Allergy & Asthma Research, LLC — South Burlington, Vermont, United States
• PI-Coor Clinical Research, LLC — Burke, Virginia, United States
• Pediatric Associates of Charlottesville, PLC — Charlottesville, Virginia, United States
• Pediatric Research of Charlottesville, LLC (Regulatory Only) — Charlottesville, Virginia, United States
• Pediatric Research of Charlottesville, LLC — Charlottesville, Virginia, United States
• Dermatology Specialists of Spokane — Spokane, Washington, United States
• Australian Clinical Research Network Pty Ltd — Maroubra, New South Wales, Australia
• The Skin Centre — Benowa, Queensland, Australia

Full record on ClinicalTrials.gov

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