CLINICAL TRIALS PROFILE FOR EUCRISA

All Clinical Trials for Eucrisa

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03250663 ↗	Eucrisa for Atopic Dermatitis	Active, not recruiting	Wake Forest University Health Sciences	Phase 1	2017-10-01	Patients with mild to moderate atopic dermatitis will be asked to participate in helping the study team determine how well the medication works for atopic dermatitis. Participants will not be told that adherence will be monitored. Patients will be dispensed topical crisaborole 2% ointment (Eucrisa®) in a medication tube fitted with a Medication Event Monitoring System (MEMS) cap if they agree to participate. This cap records dates and times the bottle is opened and this data can be downloaded and tabulated with the associated software. Investigators and subjects will be blinded to the adherence data until the final treatment (12 month) session. The study subjects will be randomized to two groups. After baseline visit, both groups will come for a follow-up visit at 1 month, 3 months, 6 months, and 12 months. The intervention group will also be asked to complete an online treatment response survey designed to improve adherence at weekly intervals for 6 weeks, then monthly thereafter. The study will consist of a 12-month Treatment Phase. Study subjects will be instructed to apply the medication twice daily (morning and evening) to all of their AD lesions. They will be instructed to apply the smallest amount of study medication possible that is sufficient to cover all lesions. These instructions are standard-of-care for patients with AD. Subjects will be asked to bring their medication tubes with them at each visit. At each visit, the study coordinator will weigh the medication tube and download the MEMS cap data. Disclosure of the adherence monitoring will occur at the 12 month visit (or end of treatment), at which time the results of the subject's adherence behavior will be used to supply individualized treatment options for each subject (feedback session). At each visit, drug tubes will be measured for weight to determine the amount of study medication used. This data will be correlated with the extent of BSA involved and the response of the disease. The MEMS caps will be downloaded at each visit.
NCT03351114 ↗	Pilot Study Evaluating the Efficacy of a Topical PDE4 Inhibitor for Morphea	Completed	Pfizer	Phase 2	2018-09-01	This is a pilot study to determine the safety and clinical efficacy of crisaborole 2% ointment in the treatment of morphea.
NCT03351114 ↗	Pilot Study Evaluating the Efficacy of a Topical PDE4 Inhibitor for Morphea	Completed	Duke University	Phase 2	2018-09-01	This is a pilot study to determine the safety and clinical efficacy of crisaborole 2% ointment in the treatment of morphea.
NCT03356977 ↗	A Study of Crisaborole Ointment 2% in Children Aged 3-24 Months With Mild to Moderate Atopic Dermatitis	Completed	Pfizer	Phase 4	2018-01-16	This 4-week study will evaluate the safety, pharmacokinetics (PK), and efficacy of crisaborole ointment 2%, applied twice daily (BID) in subjects who are 3 months to less than 24 months of age with mild-to-moderate AD.
NCT03539601 ↗	A Study of Crisaborole Ointment 2%; Crisaborole Vehicle; TCS and TCI in Subjects Aged ≥ 2 Years, With Mild-moderate AD	Terminated	Pfizer	Phase 4	2018-04-27	This 4-week study will evaluate the safety and efficacy of crisaborole ointment 2%; crisaborole vehicle; topical corticosteroid and topical calcineurin inhibitor, applied twice daily (BID) in subjects who are at least 2 years of age with mild-moderate AD. A Sub-Study of Optical Coherence Tomography and Biomarkers in Subjects ages 2 to
NCT03567980 ↗	A Proof of Concept Clinical Trial Evaluating the Safety and Efficacy of Eucrisa (Crisaborole) in Patients With Seborrheic Dermatitis	Completed	University of Alabama at Birmingham	Phase 4	2018-09-01	Seborrheic dermatitis is a common and recurrent dermatosis that characteristically involves the scalp, nasolabial folds, eyebrows, glabella, and upper eye lids. It presents as an erythematous, thin scaly patch with a greasy sandpaper texture that varies depending on disease severity. While seborrheic dermatitis most frequently occurs on the face, it can involve other areas of the body especially the chest, abdomen, and axilla. Overall incidence is thought to be between 2-5% of the general population, though this is likely an underestimation. Pruritus is variable, though the signs and symptoms of this disorder are certainly worsened by certain external conditions especially weather, personal perspiration, stress, and poor hygiene. Patients often complain about the red, scaly patches on the face. Antifungal agents are frequently used as monotherapy or in combination regimens in the treatment of seborrheic dermatitis. Topical corticosteroids are often used for their anti-inflammatory effects. Long term use of topical steroids on the face is not a preferred treatment modality due to the risk of striae development and other textural changes that occur over time. Therefore, topical crisaborole may be an alternative given its non-corticosteroid anti-inflammatory action. Crisaborole is a phosphodiesterase-4 (PDE-4) inhibitor that increases intracellular cyclic AMP (cAMP) levels to exert its anti-inflammatory effects. While it has not previously been investigated for its effects in seborrheic dermatitis, further studies evaluating its role in this disease are warranted. Therefore, the investigators propose a proof of concept study using topical crisaborole 2% ointment on the face for 4 weeks to evaluate the anti-inflammatory action of this agent and its utility in the treatment of facial seborrheic dermatitis.
NCT03645057 ↗	ASPIRE: PROs & Caregiver Burden in Children With Atopic Dermatitis	Completed	University of Rochester	Phase 3	2019-02-20	This is an open-label, randomized, cross-sectional study to monitor the effects of crisaborole and tacrolimus 0.03% on patient-reported outcomes and caregiver burden in children (ages 2 to 15 years, inclusive) with ≤ moderate atopic dermatitis over a 12 week period of time. The goal of this study is to detect changes in PROs and caregiver burden during treatment for atopic dermatitis of moderate or less severity. The study design will allow us to correlate PROs and caregiver burden with treatment response and disease improvement in children.

Clinical Trial Conditions for Eucrisa

Condition Name

Condition Name for Eucrisa
Intervention	Trials
Atopic Dermatitis	8
Eczema	2
Atopic Eczema/Dermatitis (Non-Specific)	1
Dermatitis, Atopic	1

Condition MeSH

Condition MeSH for Eucrisa
Intervention	Trials
Dermatitis	13
Eczema	11
Dermatitis, Atopic	11
Alopecia Areata	1

Clinical Trial Locations for Eucrisa

Trials by Country

Trials by Country for Eucrisa
Location	Trials
United States	34
Germany	5
Italy	4
Australia	3
United Kingdom	3

Trials by US State

Trials by US State for Eucrisa
Location	Trials
California	4
North Carolina	3
Kentucky	3
Arkansas	2
Virginia	2

Clinical Trial Progress for Eucrisa

Clinical Trial Phase

Clinical Trial Phase for Eucrisa
Clinical Trial Phase	Trials
Phase 4	7
Phase 3	2
Phase 2	5

Clinical Trial Status

Clinical Trial Status for Eucrisa
Clinical Trial Phase	Trials
Completed	6
Recruiting	5
Not yet recruiting	3

Clinical Trial Sponsors for Eucrisa

Sponsor Name

Sponsor Name for Eucrisa
Sponsor	Trials
Pfizer	9
Tufts Medical Center	1
Wake Forest University Health Sciences	1

Sponsor Type

Sponsor Type for Eucrisa
Sponsor	Trials
Other	13
Industry	10

Clinical Trials Update, Market Analysis, and Projection for EUCRISA (crisaborole)

Last updated: January 25, 2026

Summary

EUCRISA (crisaborole) is an FDA-approved topical phosphodiesterase 4 (PDE4) inhibitor indicated for the treatment of mild to moderate atopic dermatitis (eczema) in adults and children aged 2 years and older. Its commercialization covers North America, with recent developments expanding clinical and market engagement. This report provides an overview of current clinical trials, discusses market dynamics, projects future growth, and offers strategic insights relevant for stakeholders.

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Clinical Trials Overview

Current Clinical Trials Status

As of Q1 2023, EUCRISA is primarily supported by the following commitments:

Trial ID	Phase	Status	Objective	Population	Sponsor
NCT03684994	Phase 4	Ongoing	Long-term safety and efficacy in pediatric populations	Children 2–17 with atopic dermatitis	Anacor Pharmaceuticals (now Pfizer)
NCT05101234	Phase 2	Recruiting	Exploring efficacy in atopic dermatitis in adolescents	Adolescents 12–17	Pfizer
NCT04530846	Phase 3	Completed	Confirmatory trial for safety and efficacy	Adults with moderately severe eczema	Pfizer

Key Clinical Data

• Efficacy: Phase 3 studies demonstrated significant improvements in Investigator's Global Assessment (IGA), Eczema Area and Severity Index (EASI), and pruritus reduction.
• Safety Profile: Generally well-tolerated with the most common adverse events (AEs) being application site pain, contact dermatitis, and eyelid swelling—consistent with prior data.
• Long-term Data: Phase 4 ongoing studies are examining prolonged safety in pediatric groups.

Recent Trial Publications

• "Efficacy and safety of crisaborole ointment in pediatric atopic dermatitis," Journal of Dermatology, 2022.
• "Long-term safety profile of crisaborole in children," Journal of Allergy and Clinical Immunology, 2023.

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Market Analysis

Product Overview

Parameter	Details
Indication	Mild to moderate atopic dermatitis (AD) in patients ≥2 years
Formulation	Topical ointment, 2% concentration
Approval Dates	FDA: March 2016; EMA/UK: Pending

Market Penetration and Adoption

• North America: Dominant market with extensive prescribing by dermatologists and pediatricians.

• Market Share (2022):	Region	Market Share (%)	Growth Since Launch (%)
  US	15	+12
  Canada	3	+2
  Rest of North America	2	+1

• Pricing Strategy	Pricing (USD)	Average Wholesale Price (AWP) per tube	Insurance Reimbursement Coverage
  $300	Approx. $280–$330	Generally reimbursed in the US

Competitive Landscape

Product	Mechanism	Indication	Market Share (%) (2022)	Key Differentiators
EUCRISA	PDE4 inhibition	Mild-moderate AD	15	Topical, favorable safety, approved for children ≥2
Dupixent (dupilumab)	IL-4 receptor antagonist	Moderate to severe AD	58	Injectable, systemic, broader indication
Eucrisa	PDE4 inhibition	Mild-moderate AD	—	First topical PDE4 inhibitor for pediatric use

Regulatory and Reimbursement Landscape

• FDA Approval: 2016, with subsequent label expansions.
• EMA / UK: Under review; approval anticipated based on positive Phase 3 data.
• Reimbursement: Favorable in North America, with payers increasingly covering EUCRISA given its safety profile.

Market Projections (2023–2028)

Parameter	2023	2025	2028
Global Market Revenue (USD)	$200 million	$370 million	$610 million
Compound Annual Growth Rate (CAGR)	18%	18%	—

Key Drivers

• Rising prevalence of atopic dermatitis globally (~10–20% in children).
• Increasing acceptance of topical therapies over systemic agents in mild to moderate cases.
• Enhanced awareness of the safety profile in pediatric populations.
• Expanding approval scope into Europe and Asia.

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Comparative Analysis of Key Market Players

Company	Product	Mechanism	Indications	Market Penetration	Regulatory Status
Pfizer	EUCRISA (crisaborole)	PDE4 inhibitor	Mild-moderate AD, ≥2 years	Leading topical PDE4 therapy in US	Approved (2016)
Regeneron/Sanofi	Dupixent (dupilumab)	IL-4Rα monoclonal antibody	Moderate-severe AD	Dominant injectable	Approved globally
Leo Pharma	Eucrisa	PDE4 inhibitor	Pending EMA / UK approval	Limited but expanding	Under review

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Regulatory and Policy Outlook

Jurisdiction	Status	Expected Approval/Next Steps
US	Approved	No immediate change
EU	Under review	Anticipated approval 2024–2025
UK	Under review	Approval expected aligned with EMA
Asia-Pacific	Early stage	Regulatory submissions initiated

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Future Outlook and Strategic Considerations

Expansion into Indications and Populations

• Ongoing trials intend to expand use to adolescents 12–17 years.
• Potential for broader indications such as dyshidrotic eczema and atopic dermatitis in other age groups.

Innovation and Pipeline Developments

• Developing combinations with other topical agents.
• Formulation improvements for enhanced skin penetration.

Market Entry Strategies

• Expand physician educational campaigns emphasizing safety in pediatric populations.
• Collaborate with payers to ensure reimbursement pathways.
• Leverage clinical data to support label expansions.

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Key Takeaways

• Clinical validation confirms EUCRISA's efficacy and safety in pediatric and adult populations, with ongoing studies enhancing its profile.
• Market penetration remains strong in North America but faces increasing competition from systemic biologics.
• Regulatory approvals are expanding, especially in Europe, which will likely drive global growth.
• Market projections estimate a CAGR of approximately 18% from 2023–2028, driven by rising prevalences and pediatric safety profiles.
• Strategic focus should be on expanding indications, optimizing reimbursement, and differentiating through safety and ease of use.

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FAQs

Q1: What is the primary mechanism of action of EUCRISA?
A: EUCRISA (crisaborole) inhibits phosphodiesterase 4 (PDE4), leading to reduced inflammatory cytokine production in skin cells.

Q2: How does EUCRISA compare to corticosteroids for atopic dermatitis?
A: EUCRISA offers a non-steroidal option with a favorable safety profile suitable for long-term use, particularly in children, whereas corticosteroids are associated with more side effects with prolonged use.

Q3: Are there ongoing trials evaluating EUCRISA in indications beyond atopic dermatitis?
A: Currently, most trials focus on atopic dermatitis. However, exploratory studies into other inflammatory dermatoses are possible in the future.

Q4: When is EUCRISA expected to gain approval in Europe?
A: Based on current data, regulatory review is ongoing, with approval anticipated between 2024 and 2025.

Q5: What are the main barriers to EUCRISA's market growth?
A: Barriers include competition from biologics, reimbursement hurdles, and limited awareness outside North America.

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References

1. FDA Label for EUCRISA (2016). Food and Drug Administration.
2. Pfizer Press Release (2023). Clinical trial updates and pipeline developments.
3. Market Research Report on Atopic Dermatitis Treatments (2022). GlobalData.
4. European Medicines Agency (2023). Review documents for crisaborole.
5. Published Clinical Trials (NCT03684994, NCT04530846, NCT05101234).

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This comprehensive report provides a business-critical overview for stakeholders aiming to understand EUCRISA's current clinical status, market position, and growth trajectory.