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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
EfficacySteroid-free EUCRISA has proven efficacy in patients ≥2 yearsOverviewAbout ISGABaseline CharacteristicsEUCRISA was studied across a spectrum of patients

EUCRISA was studied in 2 multicenter, randomized, double-blind, vehicle-controlled trials treating 1522 patients 2 years and older with mild-to-moderate atopic dermatitis (EUCRISA n=1016, vehicle n=506)1,2

  • The study included treatment-naïve and treatment-experienced patients following an appropriate washout period2
 SELECT ENROLLMENT CRITERIA1,2

Key inclusion area:

  • 2 years of age or older
  • Clinical diagnosis of ISGA Mild (2) or Moderate (3) atopic dermatitis
  • Atopic dermatitis involvement ≥5% treatable BSA (excluding scalp)

Key exclusion criteria:

  • TCS or TCI use within 14 days of study
  • Significant active infection
  • Any previous use of biologic therapy
  • Systemic corticosteroid or immunosuppressant use within 28 days of study
a    Five patients were randomized but did not receive EUCRISA.2In the pivotal trials, races other than Caucasian included American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or other Pacific Islander, and Other.2 BASELINE CHARACTERISTICS OF PATIENTS, POOLED DATA​​​​​​​ What is vehicle?

The Emollient-rich Vehicle control used in clinical studies is the same petrolatum-based, proprietary, nonmedicated ointment formulation in EUCRISA only without the active ingredient crisaborole. Ointments contain emollients which can help lock in moisture and soften the skin.5

Utilizing a vehicle arm is a standard way to test the effect of a topical product. Comparing EUCRISA to the vehicle provided evidence of the effect of the active ingredient, crisaborole, in pivotal trials.

 Clinical trial endpoints
  • Primary efficacy endpoint
    • Proportion of patients achieving success in ISGA* at Day 29, a stringent metric, defined as Clear (0) or Almost Clear (1) AND at least a 2-grade improvement from baseline2
  • Secondary efficacy endpoints
    • Time to success in ISGA,*† defined as the proportion of patients achieving an ISGA of Clear (0) or Almost Clear (1) AND at least a 2-grade improvement from baseline2
    • Proportion of patients who achieved an ISGA of Clear (0) or Almost Clear (1) at Day 292
  • Primary safety assessments
    • Adverse events, vital signs, ECGs, and clinical laboratory parameters2
  • Other endpoints
    • Dermatology-related Quality of Life (QoL) Assessments2
      • Change from baseline in mean dermatology-related QoL scores: Children’s Dermatology Life Quality Index (CDLQI) and Dermatology Life Quality Index (DLQI)
    • Exploratory pruritus endpoints
      • Time to improvement in Pruritus: Severity of Pruritus Score (SPS)
      • Proportion of patients who achieved improvement in pruritus (SPS)
Success in ISGA, a stringent metric, is defined as Clear (0) or Almost Clear (1) AND at least a 2-grade improvement from baseline.1Physician evaluation at Days 1 (baseline), 8, 15, 22 and 29.2 BSA=body surface area; ISGA=lnvestigator's Static Global Assessment; TCl=topical calcineurin inhibitors; TCS=topical corticosteroids.ReferencesEUCRISA® (crisaborole) Full Prescribing Information. April 2023.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.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.Efficacy Pivotal Trial Primary Efficacy Endpoint Find out more about the proportion of patients who achieved Clear or Almost Clear at Day 29 in the primary endpoint Learn more Loading 3 to <24 Month Study Data Learn more about 28-day, open-label, single-arm, safety study in 3 to <24-month-old patients14 See data Loading
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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Savings & Support Program

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

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Learn how the first and only 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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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.