Clinical Trials

Crisaborole has been evaluated across numerous clinical trials spanning Early Phase 1 through Phase 4, primarily investigating dermatological inflammatory conditions such as atopic dermatitis, seborrheic dermatitis, and cetuximab-induced skin toxicity. Supported by commercial sponsors like Pfizer alongside academic institutions such as the University of California Irvine, Sun Yat-sen University, and the University of Alabama at Birmingham, these studies encompass a full range of recruitment statuses, including completed, active, terminated, and upcoming protocols.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07352566 NOT_YET_RECRUITING
Psoriasis; Atopic Dermatitis
University of California, San Francisco
 2026-08-01 PHASE4
NCT07162896 NOT_YET_RECRUITING
Atopic Dermatitis; Atopic Dermatitis (AD)
Shalamar Institute of Health Sciences
 2026-06 PHASE3
NCT07519174 NOT_YET_RECRUITING
Atopic Dermatitis
Foundation University Islamabad
 2026-06-01
NCT07438509 NOT_YET_RECRUITING
Atopic Dermatitis (AD); Atopic Eczema
Jinnah Postgraduate Medical Centre
 2026-03-01 PHASE4
NCT07437534 NOT_YET_RECRUITING
Atopic Dermatitis
Hayat Abad Medical Complex, Peshawar
 2026-03-01 PHASE4
NCT07367932 NOT_YET_RECRUITING
Dermatitis, Atopic; Eczema
Cairo University
 2026-02 PHASE4
NCT07088276 NOT_YET_RECRUITING
Vitiligo
Tanta University
 2025-08
NCT06118047 UNKNOWN
Metastatic Colorectal Cancer; Cetuximab; Skin Toxicity
Sun Yat-sen University
 2023-08-01 PHASE2
NCT07537751 COMPLETED
Atopic Dermatitis; Eczema
Noura Abdelmoneim Mohammed Elseessy
 2024-02-01
NCT05298033 COMPLETED
Vitiligo
University of Colorado, Denver
 2022-09-07 PHASE2
NCT03832010 COMPLETED
Atopic Dermatitis; Eczema
Johns Hopkins University
 2019-12-17 PHASE4
NCT05200403 TERMINATED
Atopic Dermatitis
Boston University
 2022-07-26 PHASE4
NCT04800185 COMPLETED
Atopic Dermatitis; Atopic Dermatitis Eczema
University of California, Irvine
 2021-03-23 EARLY_PHASE1
NCT04299503 WITHDRAWN
Alopecia Areata
Tufts Medical Center
 2020-03-06 PHASE2
NCT04023084 COMPLETED
Atopic Dermatitis; Eczema
Ann & Robert H Lurie Children's Hospital of Chicago
 2019-10-03 PHASE4
NCT04040192 COMPLETED
Atopic Dermatitis
Pfizer
 2019-09-12 PHASE3
NCT04091087 COMPLETED
Stasis Dermatitis
Pfizer
 2020-06-26 PHASE2
NCT04194814 COMPLETED
Atopic Eczema/Dermatitis (Non-Specific)
Sheffield Teaching Hospitals NHS Foundation Trust
 2020-11-20 PHASE2
NCT04360187 COMPLETED
Atopic Dermatitis
Pfizer
 2020-07-27 PHASE3
NCT03645057 COMPLETED
Atopic Dermatitis
University of Rochester
 2019-02-20 PHASE3
NCT04214197 UNKNOWN
Atopic Dermatitis
Massachusetts General Hospital
 2020-02-03 PHASE4
NCT04800185 Completed
Atopic Dermatitis|Atopic Dermatitis Eczema
University of California Irvine|Pfizer
 2021-03-23 Early Phase 1
NCT04498403 TERMINATED
Atopic Dermatitis
Pfizer
 2020-09-14 PHASE3
NCT03539601 TERMINATED
Atopic Dermatitis
Pfizer
 2018-04-27 PHASE4
NCT03868098 COMPLETED
Dermatitis, Atopic
Innovaderm Research Inc.
 2019-05-21 PHASE4
NCT03567980 COMPLETED
Seborrheic Dermatitis
University of Alabama at Birmingham
 2018-09-01 PHASE4
NCT03351114 COMPLETED
Morphea
Duke University
 2018-09-01 PHASE2
NCT03954158 COMPLETED
Atopic Dermatitis
Pfizer
 2019-06-15 PHASE2
NCT03954158 Completed
Atopic Dermatitis
Pfizer
 2019-06-15 Phase 2
NCT03760042 COMPLETED
Healthy
Pfizer
 2018-11-14 PHASE1
NCT03356977 COMPLETED
Atopic Dermatitis
Pfizer
 2018-01-16 PHASE4
NCT03233529 COMPLETED
Dermatitis, Atopic
Pfizer
 2017-07-31 PHASE2
NCT03260595 COMPLETED
Healthy; Atopic Dermatitis
Pfizer
 2017-09-13 PHASE1
NCT03260595 Completed
Healthy|Atopic Dermatitis
Pfizer
 2017-09-13 Phase 1
NCT02118792 COMPLETED
Dermatitis, Atopic
Pfizer
 2014-03 PHASE3
NCT02118766 COMPLETED
Dermatitis, Atopic
Pfizer
 2014-03 PHASE3
NCT01602341 COMPLETED
Dermatitis, Atopic
Pfizer
 2012-08 PHASE2
NCT01652885 COMPLETED
Dermatitis, Atopic
Pfizer
 2012-07 PHASE1; PHASE2
NCT01652885 Completed
Dermatitis Atopic
Pfizer
 2012-07 Phase 1|Phase 2
NCT01301508 COMPLETED
Dermatitis, Atopic
Pfizer
 2011-05 PHASE2
NCT01300052 COMPLETED
Psoriasis
Pfizer
 2011-01-26 PHASE2
NCT01258088 COMPLETED
Plaque-type Psoriasis
Pfizer
 2010-11-30 PHASE1
NCT01029405 COMPLETED
Psoriasis
Pfizer
 2009-11 PHASE2
NCT00755196 COMPLETED
Psoriasis
Pfizer
 2008-09 PHASE2
NCT00763204 COMPLETED
Psoriasis
Pfizer
 2008-02-29 PHASE1
NCT00759161 COMPLETED
Psoriasis
Pfizer
 2007-11 PHASE2
NCT00762658 COMPLETED
Psoriasis
Pfizer
 2007-11-30 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-06-03)

Check the Crisaborole (AN2728) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Crisaborole selectively binds to and inhibits phosphodiesterase 4 (PDE4), preventing the hydrolysis of cyclic adenosine monophosphate (cAMP) and thereby increasing intracellular cAMP concentrations in immune cells. This accumulation of cAMP downregulates the expression of pro-inflammatory cytokines, suppressing cutaneous inflammation and relieving clinical symptoms in dermatological disorders such as atopic dermatitis and seborrheic dermatitis.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.