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
Crisaborole Pfizer EfficacySteroid-Free Crisaborole Pfizer has proven efficacy in patients ≥ 2 years
See all endpoints for Efficacy
Success in ISGA was achieved by almost 3 times higher percentage of Crisaborole Pfizer patients vs vehicle at Day 8 in patients aged 2 years and older1,3*
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POOLED RESULTS FROM 2 PIVOTAL TRIALS: SUCCESS IN ISGA3
Day
Crisaborole Pfizer
(n=1016)
Vehicle
(n=506)
8
14.7%
5.4%
15
24.4%
11.0%
22
29.8%
15.9%
29
32.1%
21.8%
Time to success in ISGA is a secondary efficacy endpoint from the pivotal trials.
ISGA=Investigator’s Static Global Assessment.
This study reflects information from the pivotal trial where patients enrolled were 2 years and older.
Crisaborole Pfizer was studied across a spectrum of patients
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ReferencesCrisaborole Pfizer Full Prescribing Information. April 2020.Paller AS, Tom WL, Lebwohl MG, et al. Efficacy and safety of crisaborole ointment, a novel, nonsteroidal phosphodiesterase 4 (PDE4) inhibitor for the topical treatment of atopic dermatitis (AD) in children and adults. J Am Acad Dermatol. 2016;75(3):494-503.e4.Data on File. Pfizer Inc., New York, NY.Hongbo Y, Thomas CL, Harrison MA, Salek MS, Finlay AV. Translating the science of quality of life into practice: what do Dermatology Life Quality Index scores mean? J Invest Dermatol. 2005;125(4):659-664.Waters A, Sandhu D, Beattie P, Ezughah F, Lewis-Jones S. Severity stratification of Children's Dermatology Life Quality Index (CDLQI) scores. Br J Dermatol. 2010;163(suppl 1):121.Lewis-Jones S. Quality of life and childhood atopic dermatitis: the misery of living with childhood eczema. Int J Clin Pract. 2006;60(8):984-992.Finlay AY, Khan GK. Dermatology Life Quality Index (DLQl)-a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994;19(3):210-216.Basra MK, Salek MS, Camilleri L, Sturkey R, Finlay AV. Determining the minimal clinically important difference and responsiveness of the Dermatology Life Quality Index (DLQI): further data. Dermatology. 2015;230(1):27-33.Schünemann HJ, Guyatt GH. Commentary goodbye M(C)ID! Hello MID, where do you come from? Health Serv Res. 2005;40(2):593-597.Langley RG, Paller AS, Hebert AA, et al. Patient-reported outcomes in pediatric patients with psoriasis undergoing etanercept treatment: 12-week results from a phase Ill randomized controlled trial. J Am Acad Dermatol. 2011;64(1):64-70.Lewis-Jones MS, Finlay AV. The children's dermatology life quality index (CDLQI): initial validation and practical use. Br J Dermatol. 1995;19(3):210-216.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.
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 more about 28-day, open-label, single-arm, safety study in 3 to <24 month old patients12
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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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