• Prescribing Information
  • Patient Information
  • Patient Site
  • Phase III Study Primary Endpoint*
    Phase III Study Secondary Endpoints*
    Phase III Study: Other Endpoints*
    Infant Study: Exploratory Endpoint**

    *Phase III pivotal studies and open-label safety extension study investigated in patients 2 years and older

    **Infant study investigated patients aged 3 to <24 months

    *Phase III pivotal studies and open-label safety extension study investigated in patients 2 years and older

    **Infant study investigated patients aged 3 to <24 months

    EUCRISA Efficacy

    Steroid-Free EUCRISA has proven efficacy in patients ≥ 2 years

    Overview About ISGA Baseline Characteristics

    EUCRISA was studied across a spectrum of patients

    EUCRISA was studied in two 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

    a5 patients were randomized but did not receive EUCRISA.2

    BASELINE CHARACTERISTICS OF PATIENTS, POOLED DATA​​​​​​​

    bIn the pivotal trials, races other than Caucasian included American Indian or Alaska Native, Asian,
    Black or African American, Native Hawaiian or other Pacific Islander, Other.2

    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.1

     Physician evaluation at Days 1 (baseline), 8, 15, 22, 29.2

     ISGA=lnvestigator's Static Global Assessment; BSA=body surface area; TCS=topical corticosteroids; TCl=topical calcineurin inhibitors.

    References
    1. ​​​​​​​EUCRISA® (crisaborole) Full Prescribing Information. April 2020.
    2. 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.
    3. 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.

    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

    ** This is an optional area where footnotes can live.

    If babies could talk, what would they tell you?

    Hear JP with mild-to-moderate AD explain what EUCRISA means to him and other babies like him

    Not an actual patient

    Watch JP's story

    3 to <24 Month Study Data

    Learn more about 28-day, open-label, single-arm, safety study in 3 to <24 month old patients3

    See data

    ** This is an optional area where footnotes can live.

    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

    Learn more

    Copay Cards

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

    Terms and Conditions apply​​​​​​

    ​​​​* Patients enrolled in state or federally funded prescription insurance programs are not eligible to use this card. Savings up to $970 per tube. Annual savings up to $3,880. This card will be accepted only at participating pharmacies. This card is not health insurance.

    Download Copay cards

    ** This is an optional area where footnotes can live.

    Savings & Support Program

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

    See resources

    ** This is an optional area where footnotes can live.

    Order Samples

    Register or sign in to check availability and request samples.

    Order now

    ** This is an optional area where footnotes can live.

    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

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

    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.