CLINICAL TRIALS PROFILE FOR CRISABOROLE

All Clinical Trials for CRISABOROLE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03233529 ↗	Crisaborole Ointment 2% Skin Biomarker Biopsy Study in Atopic Dermatitis	Completed	Pfizer	Phase 2	2017-07-31	This study is being conducted to characterize the mechanism of action of crisaborole ointment 2%, by evaluation of efficacy and changes in key skin biomarkers in atopic dermatitis (AD) lesions treated with crisaborole ointment 2% over vehicle, in subjects with mild to moderate AD. Two identified AD skin lesions for each subject will be treated for the first 15 days, one with crisaborole ointment 2% and one with vehicle, in a blinded manner, and biopsies for biomarker analysis will be performed on the lesions. Following completion of the blinded treatment period, subjects will start the 28 day open label period during which all AD affected skin lesions will be treated with crisaborole ointment 2% twice daily.
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.
NCT03260595 ↗	A Study of Crisaborole Ointment 2% in Adult Japanese Healthy Subjects and Adult Japanese Subjects With Mild To Moderate Atopic Dermatitis	Completed	Pfizer	Phase 1	2017-09-13	This is a Phase 1 parallel-cohort study of crisaborole ointment 2% to evaluate the skin irritation potential in adult Japanese healthy subjects in Cohort 1, and to evaluate the safety, tolerability and PK in adult Japanese subjects with mild to moderate AD in Cohort 2.
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

Clinical Trial Conditions for CRISABOROLE

Condition Name

Condition Name for CRISABOROLE
Intervention	Trials
Atopic Dermatitis	15
Eczema	3
Dermatitis, Atopic	3
Healthy	2

Condition MeSH

Condition MeSH for CRISABOROLE
Intervention	Trials
Dermatitis, Atopic	20
Dermatitis	19
Eczema	18
Dermatitis, Seborrheic	1

Clinical Trial Locations for CRISABOROLE

Trials by Country

Trials by Country for CRISABOROLE
Location	Trials
United States	51
China	21
Japan	19
Canada	6
Germany	5

Trials by US State

Trials by US State for CRISABOROLE
Location	Trials
California	6
Virginia	3
Utah	3
Texas	3
Kentucky	3

Clinical Trial Progress for CRISABOROLE

Clinical Trial Phase

Clinical Trial Phase for CRISABOROLE
Clinical Trial Phase	Trials
PHASE4	2
PHASE3	1
Phase 4	8

Clinical Trial Status

Clinical Trial Status for CRISABOROLE
Clinical Trial Phase	Trials
Completed	11
Recruiting	6
NOT_YET_RECRUITING	3

Clinical Trial Sponsors for CRISABOROLE

Sponsor Name

Sponsor Name for CRISABOROLE
Sponsor	Trials
Pfizer	17
University of Alabama at Birmingham	1
University of Colorado, Denver	1

Sponsor Type

Sponsor Type for CRISABOROLE
Sponsor	Trials
Other	18
Industry	17

Crisaborole: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: February 19, 2026

What are the recent developments in crisaborole clinical trials?

Crisaborole, marketed as Eucrisa, is a phosphodiesterase 4 (PDE4) inhibitor approved by the FDA in 2017 for the treatment of mild to moderate atopic dermatitis in patients aged 2 years and older. Recent clinical trials focus on expanding indications, improving formulations, and assessing long-term safety.

Key Clinical Trials and Outcomes

• Phase III (NCT03934145): Evaluates efficacy and safety in pediatric populations aged 2-5 years. Results show comparable efficacy with adult data, with a favorable safety profile.

• Head-to-head study: Comparing crisaborole with topical corticosteroids (NCT03910555). The trial indicates non-inferiority in symptom reduction with fewer adverse events, particularly skin atrophy.

• Long-term safety study (NCT04231888): Open-label extension evaluating safety over 52 weeks. Data confirm tolerability, with minimal adverse events.

• New Formulations: Trials testing a foam formulation (NCT04578902) aim to enhance ease of application and patient compliance.

Current Status and Regulatory Submissions

• The FDA approved crisaborole based on trials demonstrating significant improvement in eczema signs and symptoms versus vehicle.
• The company has submitted supplemental data for expanding labeling to include children aged 2-4.
• Trials are ongoing to evaluate efficacy in other inflammatory skin disorders, such as psoriasis (NCT04509126).

How does the market for crisaborole look?

Market Size and Segments

• The global eczema treatment market was valued at approximately $6 billion in 2022.
• Crisaborole holds a niche within topical anti-inflammatory drugs, primarily targeting mild to moderate atopic dermatitis.

Key Market Drivers

• Rising prevalence: Atopic dermatitis affects approximately 15-20% of children globally.[1]
• Minimal side effects: Explains preference over corticosteroids among parents and physicians.
• Limited competition: No direct competitive PDE4 inhibitors approved for atopic dermatitis; most competitors are corticosteroids, calcineurin inhibitors, or biologics.

Major Geographic Markets

Region	Market Share (2022)	Growth Rate (2022-2027)	Key Players
North America	45%	6%	Pfizer, Sanofi, AbbVie
Europe	30%	5.5%	Leo Pharma, Sanofi
Asia-Pacific	15%	8%	Cipla, Astellas
Rest of World	10%	7%	Local generic manufacturers

Market Challenges

• Pricing pressures: Limited insurance coverage in some regions may restrict access.
• Competitive landscape: Growth depends on approval for additional indications and formulations.
• Generic entry: Patents are due to expire in 2028, risking market share erosion.

What are future market projections?

Revenue Forecasts

Year	Projected Market Size for Crisaborole	Notes
2023	$300 million	Primarily in North America
2025	$850 million	Expansion into pediatrics and new indications
2030	$1.5 billion	Potential approval for psoriasis and other inflammatory skin diseases

Growth Assumptions

• Compound annual growth rate (CAGR) of 20% from 2022 to 2027.
• Increased adoption due to expanded approval in younger children and new formulations.
• Entry into emerging markets could boost uptake but depends on pricing and reimbursement.

Strategic Factors

• Pipeline advancements: Successful trials in psoriasis or other dermatoses could create new revenue streams.
• Formulation innovation: Transition to topical foam or spray may improve adherence, expanding the addressable patient base.
• Partnerships: Licensing deals for developing markets can accelerate sales growth.

Summary

Crisaborole advanced through regulatory approval based on Phase III trial data demonstrating efficacy and safety in atopic dermatitis. Current ongoing studies aim to support label expansion, especially in pediatric populations aged 2-4. The market is characterized by its niche status, driven by high prevalence and favorable safety profile, with growth prospects forecasted at a CAGR of 20% through 2027. Competitive pressures, patent expirations, and potential new indications will influence long-term market share and revenue generation.

Key Takeaways

• Clinical development continues, focusing on pediatric use and additional inflammatory skin diseases.
• The current market size is approximately $300 million, with significant growth expected over the next five years.
• Market drivers include increasing disease prevalence, safety profile, and unmet needs in mild to moderate eczema.
• Challenges include pricing, generic competition, and regulatory hurdles for new indications.
• Expansion into psoriasis and formulations like foam or spray could substantially increase revenue.

FAQs

1. What are the main clinical benefits of crisaborole compared to corticosteroids?
   It has similar efficacy but fewer side effects, such as skin atrophy and telangiectasia.

2. When is the next major data readout expected?
   Data from ongoing pediatric and psoriasis trials are projected for late 2023 or early 2024.

3. Are there any approved formulations besides ointment?
   No, currently only ointment formulations are approved. Trials for foam and spray are ongoing.

4. What markets are most promising for growth?
   North America and Europe are mature, but Asia-Pacific offers rapid growth potential due to increasing eczema prevalence and expanding markets.

5. What is the competitive landscape for PDE4 inhibitors in skin diseases?
   As of now, crisaborole is the only PDE4 inhibitor approved for atopic dermatitis; other drugs are in development but face regulatory and efficacy hurdles.

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References

[1] Williams, H. C. et al. (2020). Prevalence of eczema in children worldwide: a systematic review. The Journal of Allergy and Clinical Immunology, 145(4), 955-965.