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HomeAboutAboutMechanism of ActionMechanism of ActionEfficacyEfficacyPhase III Study Primary EndpointsSuccess in ISGA: Clear or almost clearStudy DesignPhase III Study Secondary EndpointsISGA clear or almost clearTime to ISGA successPhase III Study: Other EndpointsPruritusQuality of life assessmentsInfant Study: Exploratory efficacy EndpointsISGA clear or almost clear%BSA, EASI & POEMSafetySafetyImportant Safety InformationPhase III Study Adverse Reactions*Pivotal trial & 48-week extension study Adverse ReactionsOpen-Label Safety Extension Study*Open-Label Safety Extension Study Rescue Therapy EndpointStudy designInfant Safety Study**Adverse ReactionsStudy design and DemographicsDosingMedical InformationVisit the Pfizer Medical Information Africa Website for Healthcare ProfessionalsSubmit a medical question to Pfizer

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Crisaborole Pfizer Efficacy

See all endpoints for Efficacy

An open-label, single-arm, 28 day safety trial of 137 infant patients aged 3 to <24 months in which efficacy was an exploratory objectiveISGA responses by week

ISGA SUCCESS

ISGA CLEAR OR ALMOST CLEAR

At Baseline, 38.0% of the patients had an ISGA score of 2 (Mild), and 61.3% had an ISGA score of 3 (Moderate) 2
Success in ISGA, a stringent metric, is defined as Clear (0) AND at least a 2-grade improvement from baseline

Please see Phase III Pivotal Trial Results in patients 2 years and older under Efficacy and Safety.

Crisaborole Pfizer was studied in patients aged 3 to <24 months

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ReferencesCrisaborole Pfizer (crisaborole) Full Prescribing Information. April 2020.Schlessinger J, Shepard JS, Gower R, et al. Safety, effectiveness, and pharmacokinetics of crisaborole in infants aged 3 to <24 months with mild-to-moderate atopic dermatitis: a phase IV open-label study (CrisADe CARE 1). Am J Clin Dermatol. 2020. 21:275-284. 3 to <24 Month Study Data

Learn more about 28-day, open-label, single-arm, safety study in 3 to <24 month old patients2

 See data Loading Proportion of patients with ISGA Clear or Almost Clear

Find out more about the proportion of patients aged 2 years and older who achieved ISGA clear or almost clear at day 29 from the Phase III trial's secondary endpoint

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Learn how nonsteroidal topical PDE4 inhibitor works within the skin1

The specific mechanism(s) of action of crisaborole in atopic dermatitis is not well defined. PDE4=phosphodiesterase 4

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