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crisaborole

Phase 2

Stasis Dermatitis | Small molecule | Dermatology |Pfizer, Inc.|Last Updated: May 2, 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindSHAM_CONTROLLED
Total Trials1
Total Enrollment66

FDA Designations

No designations recorded

Clinical trial landscape

crisaborole · 1 trial · 1 indication

Phase 2 1
NCT04091087Study Evaluating Efficacy and Safety of Crisaborole in Adults With Stasis DermatitisStasis Dermatitis
COMPLETED66 Analytics
PHASE2COMPLETED
Study Evaluating Efficacy and Safety of Crisaborole in Adults With Stasis Dermatitis
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Study Endpoints

Primary Endpoints

Percent Change From Baseline in Total Sign Score (TSS) at Week 6: In-person Assessment
Baseline, Week 6

TSS assesses severity of stasis dermatitis lesions. There were following 4 clinical signs of all treatable stasis dermatitis lesions: erythema, papulation/elevation, superficial erosion/denudation, and scaling. Each of 4 signs were rated on a scale of 0 to 3 (0= none, 1= mild, 2= moderate, 3= severe). TSS = sum of scores from all clinical signs; ranging from 0 (none) to 12 (most severe), where higher score indicated greater severity. The assessment was completed in person by the home visit practitioner.

Secondary Endpoints

Percentage of Participants Who Achieved Treatment Success Based on Investigator's Static Global Assessment (ISGA) at Week 6: In-person Assessment
Week 6
Percentage of Participants Who Achieved Treatment Success Based on Investigator's Static Global Assessment (ISGA) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment
Week 1, 2, 3, 4, 5 and 6
Percentage of Participants With an Investigator's Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) at Week 6: In-person Assessment
Week 6
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
crisaborole ointmentEXPERIMENTALcrisaborole ointment
vehicle ointmentSHAM_COMPARATORvehicle ointment

Interventions

NameTypeDescription
crisaborole ointmentDRUGcrisaborole ointment
vehicle ointmentOTHERvehicle ointment
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Eligibility Criteria

Age Range45 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Participants who are ≥45 years of age and in generally stable health * Participants who are in generally stable health and have a known diagnosis of Stasis Dermatitis or newly diagnosed Stasis Dermatitis * Participants whose mental and physical status allows them to be able to...

Countries:United States
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Frequently asked questions about crisaborole

What is Crisaborole 2% used for?

Crisaborole 2% is an investigational small molecule being developed for dermatological conditions, including atopic dermatitis, stasis dermatitis, and healthy skin studies. It is a topical ointment studied for treating mild-to-moderate atopic dermatitis in pediatric and adult patients, with clinical trials conducted across multiple countries.

Who makes Crisaborole 2%?

Crisaborole 2% is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. Pfizer is conducting clinical trials to evaluate the safety and efficacy of this topical ointment for dermatological indications.

What phase is Crisaborole 2% in?

Crisaborole 2% is in Phase 3 clinical development, based on completed Phase 3 trials. It remains investigational and is not yet approved by regulatory authorities. The development program includes multiple completed trials, with the most advanced being Phase 3 studies in atopic dermatitis.

What clinical trials is Crisaborole 2% in?

Crisaborole 2% has been studied in several completed clinical trials, including NCT03233529, a Phase 2 skin biomarker biopsy study in atopic dermatitis; NCT03954158, a Phase 2 study in Japanese participants; NCT04040192, a Phase 3 long-term maintenance study; and NCT04360187, a Phase 3 study in Chinese and Japanese subjects.

Is Crisaborole 2% the same as other names?

Crisaborole 2% is the drug name used in clinical trials, and no alternative names have been reported. It is consistently referred to as crisaborole ointment 2% across the studies, with no other brand or generic names mentioned in the available data.