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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 CardsCost and Coverage
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 StudyInfant Open-Label Safety trial in patients aged 3 to <24 months2

An open-label, single arm study to evaluate the safety of EUCRISA in 137 infants aged 3 to <24 months with mild-to-moderate atopic dermatitis (AD).

STUDY DESIGN OVERVIEWPhase 4, multicenter, open-label single-arm study to evaluate the safety of crisaborole ointment, 2%.Patients were excluded from the PK cohort if they had lesions below their wrists and ankles or within 2 cm of the mouth.
Crisaborole
Non-PK Cohort 

n=116		 PK Cohort 

n=21		 Total 

n=137
Study Demographics
    Crisaborole  
Non-PK Cohort 
n = 116		 PK Cohort 
n = 21		 Total 
n = 137
                                                                                           Crisaborole
                              Non-PK Cohort
              n=116
 PK Cohort
n=21		 Total
 n=137

Primary endpoints

  • Incidence of treatment-emergent adverse events (TEAEs), including site reactions and serious AEs
  • Clinically significant changes in height, weight, vital signs, physical exam, ECG, and clinical laboratory parameters
Exploratory PK endpoints
  • Crisaborole maximum observed plasma concentration (Cmax)
  • Crisaborole time to reach maximum observed plasma concentration (Tmax)
  • Crisaborole area under plasma concentration-time profile for the dosing interval (AUCtau)
  • Propylene glycol concentrations
Exploratory efficacy endpoints
  • Proportion of patients achieving ISGA success (defined as Clear [0] or Almost Clear [1] with ≥2-grade improvement from baseline)
  • Proportion of patients who achieved ISGA Clear or Almost Clear
  • Percent change from baseline in EASI score
  • Change from baseline in %BSA
  • Change from baseline in total POEM
Study Population
  • Non-PK cohort: mild to moderate AD (ISGA 2 or 3) with ≥5% treatable BSA, excluding scalp
  • PK cohort: Moderate AD (ISGA 3) with ≥35% treatable BSA, excluding scalp
Treatment
  • Crisaborole ointment, 2%, BID applied to all treatable AD-involved areas identified at Baseline/Day 1 and any new AD-involved areas that appeared following Baseline/Day 1
  • Non-PK cohort: Baseline AM dosing at study site followed by BID dosing at home from Baseline PM dose through Day 28
  • PK cohort: BID dosing at study site from Baseline to Day 8 AM dose; BID dosing at home from Day 8 PM dose through Day 28
Limitations
  • Outcomes were reported by a caregiver or investigator
  • Open-label study without a comparator group
Age (months)
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3 to <9, n (%) 36 (31.0) 7 (33.3) 43 (31.4)
9 to <24, n (%) 80 (69.0) 14 (66.7) 94 (68.6)
Mean (SD) 13.7 (6.41) 12.7 (6.58) 13.6 (6.42)
Median (range) 13.5 (3–23) 13.0 (3–23) 13.0 (3–23)
Sex, n (%)
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Male 75 (64.7) 13 (61.9) 88 (64.2)
Female 41 (35.3) 8 (38.1) 49 (35.8)
Race, n (%)
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White 71 (61.2) 13 (61.9) 84 (61.3)
Black or African American  9 (7.8) 2 (9.5) 11 (8.0)
Asian 23 (19.8) 4 (19.0) 27 (19.7)
American Indian or Alaskan native 1 (0.9) 0 1 (0.7)
Native Hawaiian or other Pacific Islander 1 (0.9) 0 1 (0.7)
Multiracial 11 (9.5) 2 (9.5) 13 (9.5)
ISGA
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2 – Mild, n (%) 52 (44.8) 0 52 (38.0)
3 – Moderate, n (%) 64 (55.2) 20 (95.2) 84 (61.3)
4 – Severe,a n (%) 0 1 (4.8) 1 (0.7)
Mean (SD) 2.6 (0.50) 3.0 (0.22) 2.6 (0.50)
Median (range) 3.0 (2–3) 3.0 (3–4) 3.0 (2–4)
POEM total score
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Mean (SD) 13.9 (5.86) 19.7 (5.18) 14.8 (6.12)
Median (range) 14.0 (1–24) 20.0 (9–27) 15.0 (1–27)
EASI score
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Mean (SD) 10.4 (8.16) 19.8 (4.42) 11.8 (8.41)
Median (range) 7.8 (1.6–38.8) 19.5 (12.5–29.2) 8.9 (1.6–38.8)
%BSA
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Mean (SD) 23.5 (20.13) 53.5 (12.61) 28.1 (22.00)
Median (range) 15.5 (5.0–94.0) 56.0 (35.0–79.0) 19.0 (5.0–94.0)
Duration Since Onset (months)
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Mean (SD) 10.4 (6.44) 9.1 (5.48) 10.2 (6.3)
Median (range) 9.4 (0.03–23.8) 8.1 (1.4–21.0) 8.6 (0.03–23.8)
Medical History of Other Atopic Conditions,b n (%) 
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  21 (18.1)     1 (4.8) 22 (16.1)
Prior Medication Use, n (%)
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TCS 63 (54.3) 9 (49.2) 72 (52.6)
TCI 2 (1.7) 0 2 (1.5)
%BSA=percentage of treatable body surface area; EASI=Eczema Area and Severity Index; ISGA=Investigator's Static Global Assessment; PK=pharmacokinetics; POEM=Patient-Oriented Eczema Measure; SD=standard deviation; TCI=topical calcineurin inhibitor; TCS=topical corticosteroid.aProtocol deviation.bIncludes conditions, such as asthma, food allergies, and allergic/seasonal rhinitis.
ReferencesEUCRISA® (crisaborole) Full Prescribing Information. April 2023.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.
Safety Data Phase 3 Study Safety Data

Find out more about EUCRISA's adverse event profile in patients 2 years and older from the pivotal studies

Learn more Loading Rescue Therapy Endpoint

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

Learn more 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 as a Phase 3 trial's secondary endpoint

Learn more Loading Exploratory Pruritus Endpoint

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

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

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PP-EUC-USA-0032
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.