A Study of Crisaborole Ointment 2%; Crisaborole Vehicle; TCS and TCI in Subjects Aged ≥ 2 Years, With Mild-moderate AD

Stopped early · Phase 4

Conditions studied: Atopic Dermatitis

In brief

This 4-week study will evaluate the safety and efficacy of crisaborole ointment 2%; crisaborole vehicle; topical corticosteroid and topical calcineurin inhibitor, applied twice daily (BID) in subjects who are at least 2 years of age with mild-moderate AD. A Sub-Study of Optical Coherence Tomography and Biomarkers in Subjects ages 2 to \<18 years old, with Mild to Moderate Atopic Dermatitis, treated with Crisaborole Ointment, 2% or Crisaborole Vehicle Ointment or Hydrocortisone Butyrate 0.1% Cream applied BID will also be conducted at select sites.

Key facts

Study ID

NCT03539601

Run by

Pfizer

People needed

237

Starts

2018-04-27

Expected to finish

2020-12-11

Last updated by the study team

2022-01-10

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Is male or female 2 years and older at the Screening visit/time of informed consent/assent diagnosed with mild-moderate AD (according to the criteria of Hanifin and Rajka), of at least 5% BSA.

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.
• Subjects in Cohort 1 are excluded if they have a contraindication for treatment with hydrocortisone butyrate cream 0.1%
• Subjects in Cohort 2 are excluded if they have a contraindication for treatment with pimecrolimus cream, 1%

Where it is running

• Dermatology Trial Associates — Bryant, Arkansas, United States
• California Dermatology & Clinical Research Institute — Encinitas, California, United States
• Park Avenue Dermatology — Orange Park, Florida, United States
• Lenus Research & Medical Group, LLC — Sweetwater, Florida, United States
• ForCare Clinical Research — Tampa, Florida, United States
• DS Research — Louisville, Kentucky, United States
• M3-Wake Research, Inc. — Raleigh, North Carolina, United States
• Arlington Research Center, Inc. — Arlington, Texas, United States
• Tanner Clinic — Layton, Utah, United States
• Virginia Clinical Research, Inc — Norfolk, Virginia, United States
• Klinikum der Universitat Munchen — München, Bavaria, Germany
• Fachklinik Bad Bentheim, Fachbereich Dermatologie und Allergologie, Dermatologische Ambulanz — Bad Bentheim, Lower Saxony, Germany
• Universitatsklinikum Bonn — Bonn, North Rhine-Westphalia, Germany
• Universitatsklinikum Schleswig-Holstein, Campus Lubeck — Lübeck, Schleswig-Holstein, Germany
• ISA - Interdisciplinary Study Association GmbH — Berlin, Germany
• Universitaetsklinikum Frankfurt — Frankfurt am Main, Germany
• UOSD Dermatologia Gen. ed Oncologica DU, PO San Salvatore — L’Aquila, AQ, Italy
• DiSSal Sezione di Dermatologia Az. Ospedaliera Universitaria — Genova, GE, Italy
• Ospedale San Pietro Fatebenefratelli — Roma, RM, Italy
• Azienda Ospedaliero - Universitaria Policlinico Tor Vergata — Roma, ROME, Italy
• Barbara Rewerska Diamond Clinic — Krakow, Malopolska, Poland
• Silmedic sp. z o.o — Katowice, Poland
• Krakowskie Centrum Medyczne sp. z o.o. — Krakow, Poland
• Klinika Ambroziak Sp. z O. O. — Warsaw, Poland
• ROYALDERM Agnieszka Nawrocka — Warsaw, Poland

Full record on ClinicalTrials.gov

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