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HomeEfficacy

Phase 3 Study: Primary Endpoints

Success in ISGA: Clear or Almost ClearStudy Design

Phase 3 Study: Secondary and Other Endpoints

ISGA Clear or Almost ClearTime to ISGA successPhase 3 Study: Other EndpointsPruritusQuality of Life AssessmentsInfant Study: Exploratory EndpointsISGA Clear or Almost Clear%BSA, EASI & POEM52-Week TrialSafety DataSafety DataPhase 3 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 Demographics52-Week Trial52-Week TrialReal PatientsReal Patient Case ReportsHand and FingerFace and NeckOtherHand and Finger5-yr-old Caucasian Female - Hands8-yr-old Caucasian Female - Hands15-yr-old Caucasian Male - Hand55-yr-old Caucasian Female - Hand64-yr-old Caucasian Female - Digit70-yr-old Caucasian Male - ThumbFace and Neck15-yr-old Caucasian Male - Chin18-yr-old Hispanic Female - Face and Neck75-yr-old Caucasian Male - FaceOther39-yr-old Asian Male - Arm44-yr-old African American Female - Leg72-yr-old Caucasian Female - LegDosingSavings & SupportSavings & SupportEventsMaterialsVideosCopay Cards
Prescribing InformationPatient Information Indication Patient Site
Safety DataSafety profile established in 5 studies, including Pivotal and Open-Label Safety Extension Studies, and an Open-Label Infant Safety StudyEUCRISA study design for 52-Week Trial1,2Trial 3 was a randomized, double-blind, vehicle-controlled Phase 3 clinical trial treating 254 patients (125 EUCRISA; 129 Vehicle), 3 months of age and older, who had responded to EUCRISA twice daily by achieving both ISGA 0 or 1 with a ≥2 grade improvement from baseline, and an EASI-50 response (defined as at least 50% improvement from baseline in Eczema Area and Severity Index scores) during an up to 8-week open-label run-in period (497 patients entered the open-label period). These patients were randomized 1:1 into a double-blind period to receive EUCRISA or Vehicle once daily for 52 weeks or until they developed a flare (ISGA ≥2).Study Design1,2

Trial 3 was a randomized, double-blind, vehicle-controlled Phase 3 clinical trial treating 254 patients (125 EUCRISA; 129 Vehicle), 3 months of age and older, who had responded to EUCRISA twice daily by achieving both ISGA 0 or 1 with a ≥2 grade improvement from baseline, and an EASI50 response (defined as at least 50% improvement from baseline in Eczema Area and Severity Index scores) during an up to 8-week open-label run-in period (497 patients entered the open-label period). These patients were randomized 1:1 into a double-blind period to receive EUCRISA or Vehicle once daily for 52 weeks or until they developed a flare (ISGA ≥2).

Established safety profile1

The most common adverse reaction occurring in ≥1% of patients in the pivotal trials was application site pain (burning and stinging); EUCRISA (n=1012) 4% vs Vehicle (n=499) 1% in Trials 1 and 2. 

The adverse reactions observed in the open-label period were similar to the known safety profile of twice daily treatment with EUCRISA. The adverse reactions observed with once daily treatment were similar to vehicle.

If the signs and symptoms of hypersensitivity occur, discontinue EUCRISA immediately and initiate appropriate therapy. EUCRISA has not been studied in clinical trials beyond 52 weeks.

ReferencesEUCRISA® (crisaborole) Full Prescribing Information. April 2023.Data on File. Pfizer Inc., New York, NY.
Safety Data Rescue Therapy Endpoint

Read about rescue therapy in the 48 week Open-Label Safety Extension Study

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Find out more about the time to relief in pruritus as found as a Phase 3 study's exploratory endpoint

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Copay Cards Eligibility required. No membership fees. This is not health insurance. Individual savings limited to $970 per tube or $3,880 in maximum total savings per calender year. Only for use with commercial insurance. If you are enrolled in a state or federally funded prescription insurance program, you may not use the copay card. Terms and Conditions apply.

*Eligible patients pay as little as $10​​​​​​

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A savings and support program for your eligible patients to help them with their access to EUCRISA*

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INDICATION

EUCRISA (crisaborole) is indicated for topical treatment of mild-to-moderate atopic dermatitis in adult and pediatric patients 3 months of age and older.

EUCRISA is for topical use only and is not for ophthalmic, oral, or intravaginal use. For more information, please view the full prescribing information here.

Indication EUCRISA (crisaborole) is indicated for topical treatment of mild‑to‑moderate atopic dermatitis in adult and pediatric patients 3 months of age and older. EUCRISA is for topical use only and is not for ophthalmic, oral, or intravaginal use. For more information, please view the full prescribing information here.
Important Safety Information Contraindications

EUCRISA is contraindicated in patients with known hypersensitivity to crisaborole or any component of the formulation.

Warnings and Precautions

Hypersensitivity reactions, including contact urticaria, have occurred in patients treated with EUCRISA and should be suspected in the event of severe pruritus, swelling, and erythema at the application site or at a distant site. Discontinue EUCRISA immediately and initiate appropriate therapy if signs and symptoms of hypersensitivity occur.

Adverse Reactions

The most common treatment-related adverse reaction occurring in clinical trials was application site pain, such as burning or stinging.

Please see Full Prescribing Information and Patient Information. Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum. Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut. Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum. Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut. IndicationEUCRISA (crisaborole) is indicated for topical treatment of mild-to-moderate atopic dermatitis in adult and pediatric patients 3 months of age and older.