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.

Clinical Trial Conditions for Crisaborole

Condition Name

Condition Name for Crisaborole
Intervention	Trials
Atopic Dermatitis	13
Dermatitis, Atopic	2
Eczema	2

Condition MeSH

Condition MeSH for Crisaborole
Intervention	Trials
Dermatitis	19
Eczema	17
Dermatitis, Atopic	17

Clinical Trial Locations for Crisaborole

Trials by Country

Trials by Country for Crisaborole
Location	Trials
United States	50
China	21
Japan	19
Canada	6
Germany	5

Trials by US State

Trials by US State for Crisaborole
Location	Trials
California	5
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
Phase 4	8
Phase 3	4
Phase 2	8

Clinical Trial Status

Clinical Trial Status for Crisaborole
Clinical Trial Phase	Trials
Completed	11
Recruiting	6
Active, not recruiting	3

Clinical Trial Sponsors for Crisaborole

Sponsor Name

Sponsor Name for Crisaborole
Sponsor	Trials
Pfizer	17
University of Rochester	1
Sun Yat-sen University	1

Sponsor Type

Sponsor Type for Crisaborole
Sponsor	Trials
Industry	17
Other	15

Crisaborole: Clinical Trials, Market Analysis, and Projections

Last updated: December 31, 2024

Introduction to Crisaborole

Crisaborole, marketed under the brand name Eucrisa, is a steroid-free topical treatment primarily used for the management of mild to moderate atopic dermatitis (AD). It is known for its anti-inflammatory properties and is an attractive alternative to traditional corticosteroids due to its favorable safety profile.

Clinical Trials Update

Phase 4 Study in Pediatric Patients

A significant recent development in the clinical trials of crisaborole is the Phase 4 study conducted by Pfizer, which focused on children aged 3 months to less than 24 months with mild to moderate atopic dermatitis. The study, known as CrisADe CARE 1, demonstrated that crisaborole ointment, 2%, was well-tolerated over a 4-week treatment period. The primary endpoints included the number of patients with treatment-emergent adverse events (AEs) and severe adverse events (SAEs), as well as clinically significant changes in various health parameters. The results reinforced the safety and efficacy of crisaborole in this young patient population[1].

Long-Term Maintenance and Flare Reduction

The CrisADe CONTROL study, a 52-week Phase III trial, evaluated the efficacy and safety of once-daily crisaborole ointment, 2%, for long-term maintenance treatment and flare reduction in patients with mild to moderate AD. This study included patients aged 3 months and older and showed that crisaborole was effective and well-tolerated for maintaining flare-free periods and reducing the frequency of flares. The trial also highlighted the drug's ability to maintain pruritus response until the onset of the first flare[4].

Efficacy and Safety Profile

Clinical Efficacy

Clinical trials, such as AD-301 and AD-302, have consistently shown that crisaborole is more effective than vehicle in achieving treatment success, defined by the Investigator's Static Global Assessment (ISGA) score. These studies demonstrated that a larger percentage of patients treated with crisaborole achieved clear or almost clear skin with at least a 2-grade improvement from baseline compared to those treated with vehicle[3].

Safety Profile

Crisaborole has been shown to have a favorable safety profile. The CrisADe CARE 1 study and other trials have indicated that crisaborole is well-tolerated, with a safety profile consistent with previous clinical trial experience. While there was a numerically higher risk of application site pain, there was no increased risk of withdrawal due to adverse events (WDAE)[1][3].

Market Analysis

Market Drivers

The crisaborole market is driven by several key factors:

• Increasing Prevalence of Skin Diseases: The rising prevalence of atopic dermatitis and other skin conditions is a significant driver. Atopic dermatitis affects a substantial portion of the population, particularly children, and is estimated to represent around 10-20% of those with skin inflammation[2].
• Demand for Non-Steroidal Treatments: There is a growing demand for non-steroidal topical treatments due to concerns about the long-term use of corticosteroids. Crisaborole fills this gap as a steroid-free alternative[5].
• Rising Awareness and Healthcare Expenditures: Increased awareness of skin diseases and higher healthcare expenditures in regions like North America and Europe are driving the market growth[2][5].

Market Restraints

Despite the positive trends, there are several restraints to the market:

• High Production Costs: The high costs associated with the production of crisaborole can pose a challenge to market expansion[5].
• Stringent Regulatory Requirements: The stringent regulatory environment can slow down the approval and launch of crisaborole products in various jurisdictions[5].
• Adverse Side Effects: Although rare, adverse side effects such as application site pain can affect patient adherence and market acceptance[3].

Market Opportunities

The crisaborole market presents several opportunities:

• Emerging Markets: Expanding into emerging markets with improving healthcare infrastructure offers significant growth potential. Regions like Asia-Pacific, particularly countries such as India and China, are expected to be key growth areas[2][5].
• Personalized Medicine: The trend towards personalized medicine and precision dermatology could further integrate crisaborole into broader therapeutic protocols, enhancing its market position[5].

Market Projections

Regional Market Analysis

• North America: This region is expected to dominate the crisaborole market due to the higher prevalence of skin diseases, increased awareness, and better healthcare infrastructure[2].
• Europe: Europe is anticipated to be the second most lucrative region, driven by similar factors as North America[2].
• Asia-Pacific: This region is expected to be the fastest-growing market, driven by a large population and increasing awareness and treatment of skin diseases[2].

Key Players and Competitive Landscape

The crisaborole market is moderately competitive, with key players such as Synergy Pharmaceuticals, Ausun Pharmaceuticals, Tapi Teva, Neurax Pharma, and VIRUJ PHARMA. These companies are engaging in strategic collaborations and significant investments in research and development to enhance their market position[2][5].

Future Insights and Trends

Innovation and R&D

The future of the crisaborole market is likely to be shaped by ongoing research and development. Areas ripe for innovation include developing combination therapies for enhanced efficacy and exploring novel applications of crisaborole in other inflammatory conditions[5].

Regulatory Landscape

The evolving regulatory landscape, which facilitates smoother approval processes for topical treatments, offers potential opportunities for the growth of the crisaborole market. Stakeholders are recommended to engage in strategic partnerships and invest in R&D to enhance formulations and delivery mechanisms[5].

Key Takeaways

• Clinical Efficacy and Safety: Crisaborole has demonstrated efficacy and a favorable safety profile in clinical trials, making it a viable option for mild to moderate atopic dermatitis.
• Market Growth Drivers: Increasing prevalence of skin diseases, demand for non-steroidal treatments, and rising healthcare expenditures are key drivers of the crisaborole market.
• Regional Market Potential: North America, Europe, and Asia-Pacific are significant regions for market growth, with Asia-Pacific expected to be the fastest-growing.
• Innovation and R&D: Ongoing research and development are crucial for enhancing the market position of crisaborole, particularly in areas such as combination therapies and novel applications.

FAQs

What is crisaborole used for?

Crisaborole is used for the treatment of mild to moderate atopic dermatitis (AD), also known as eczema. It is a steroid-free topical treatment.

What are the key findings from the Phase 4 study of crisaborole in pediatric patients?

The Phase 4 study, CrisADe CARE 1, showed that crisaborole ointment, 2%, was well-tolerated in children aged 3 months to less than 24 months with mild to moderate AD over a 4-week treatment period.

How effective is crisaborole for long-term maintenance treatment of atopic dermatitis?

The CrisADe CONTROL study demonstrated that once-daily crisaborole ointment, 2%, was effective and well-tolerated for long-term maintenance treatment and flare reduction in patients with mild to moderate AD.

What are the main drivers of the crisaborole market?

The main drivers include the increasing prevalence of skin diseases, demand for non-steroidal treatments, and rising healthcare expenditures, particularly in regions like North America and Europe.

What are the potential challenges to the growth of the crisaborole market?

High production costs, stringent regulatory requirements, and adverse side effects are potential challenges to market expansion.

Which regions are expected to be the most lucrative for the crisaborole market?

North America is expected to dominate the market, followed by Europe, while Asia-Pacific is anticipated to be the fastest-growing region.

Sources

1. Pfizer Announces Positive Top-Line Results from Phase 4 Study of Crisaborole Ointment, 2%, in Children Aged 3 Months to Less Than 24 Months with Mild to Moderate Atopic Dermatitis. Pfizer.
2. Crisaborole Market - Global Industry Analysis 2014. Persistence Market Research.
3. CDR Clinical Review Report for Eucrisa. Canada's Drug Agency.
4. Once-Daily Crisaborole Ointment, 2%, as a Long-Term Maintenance Treatment and Flare Reduction in Adult and Pediatric Patients with Mild-to-Moderate Atopic Dermatitis. PubMed.
5. Crisaborole API Market Size & Share 2025-2030. 360 Research Reports.