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Efficacy
Phase III Study Primary Endpoints
Success in ISGA: Clear or almost clear
Study Design
Phase III Study Secondary Endpoints
ISGA clear or almost clear
Time to ISGA success
Phase III Study: Other Endpoints
Pruritus
Quality of life assessments
Infant Study: Exploratory efficacy Endpoints
ISGA clear or almost clear
%BSA, EASI & POEM
Safety Data
Phase III Study Adverse Reactions*
Pivotal trial & 48-week extension study
Adverse Reactions
Open-Label Safety Extension Study*
Open-Label Safety Extension Study Rescue Therapy Endpoint
Study design
Infant Safety Study**
Adverse Reactions
Study design and Demographics
Savings & Support
Events
Materials
Videos
Copay Cards
Cost and Coverage
EUCRISA Safety Data
Safety profile established in 4 studies, including pivotal and open-label safety extension studies, and an open-label infant safety study
PIVOTAL TRIALS ADVERSE REACTIONS IN ≥1% PATIENTS
EUCRISA (n=1012) |
Vehicle (n=499) |
|
APPLICATION SITE PAIN1 |
4% (n=45) |
1% (n=6) |
| ||
APPLICATION SITE PAIN1 |
|
EUCRISA (n=1012) |
4% (n=45) |
Vehicle (n=499) |
1% (n=6) |
| |
*This pooled data reflects information from Trial 1 and Trial 2 of the pivotal trials where patients enrolled were 2 years and older
TREATMENT-RELATED ADVERSE EVENTS OCCURRING IN ≥1% OF PATIENTS IN THE OPEN LABEL SAFETY EXTENSION STUDY
EUCRISA (n=517) | |
|---|---|
APPLICATION SITE PAIN2 |
2% (n=12) |
APPLICATION SITE INFECTION2 |
1% (n=6) |
ATOPIC DERMATITIS2 |
3% (n=16) |
SAE=serious adverse event | |
EUCRISA (n=517) | |
APPLICATION SITE PAIN2 |
2% (n=12) |
APPLICATION SITE INFECTION2 |
1% (n=6) |
ATOPIC DERMATITIS2 |
3% (n=16) |
SAE=serious adverse event | |
Patients enrolled in the open label safety extension study were enrolled following the pivotal trial and were followed for 48 weeks. The total period followed was 52 weeks.
*This pooled data reflects information from Trial 1 and Trial 2 of the pivotal trials where patients enrolled were 2 years and older
†As per verbatim terms coded using the Medical Dictionary for Regulatory Activities (MedDRA) by System Organ Class/Preferred Term.
†One treatment-emergent adverse event of skin striae at application site was reported (possibly related to study drug).
- EUCRISA® (crisaborole) Full Prescribing Information. April 2020.
- Data on File. Pfizer Inc., New York, NY.
- 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.
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
** This is an optional area where footnotes can live.
Rescue Therapy Endpoint
Read about rescue therapy in the 48 week Open-Label Safety Extension study
** This is an optional area where footnotes can live.
Exploratory Pruritus Endpoint
Find out more about the time to relief in pruritus as found in the Phase III study's exploratory endpoint
** 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
** This is an optional area where footnotes can live.
Copay Cards
*Eligible patients pay as little as $10
*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.
** 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
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Order Samples
Register or sign in to check availability and request samples.
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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.
Please see full Prescribing Information.
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