Dose Ranging Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of PF-06700841 Topical Cream in Participants With Mild or Moderate Atopic Dermatitis

Completed · Phase 2 · Has a placebo group

Conditions studied: Atopic Dermatitis

In brief

This study is being conducted to provide data on efficacy, safety, tolerability and PK of multiple topical formulation concentrations of PF-06700841 topical cream in the treatment of mild to moderate atopic dermatitis (AD). The study is intended to enable selection of the dose and dosing regimen (once daily \[QD\] vs twice daily \[BID\] application) for the future clinical development of topical PF-06700841.

Key facts

Study ID

NCT03903822

Run by

Pfizer

People needed

292

Starts

2019-05-13

Expected to finish

2020-05-07

Last updated by the study team

2021-03-29

Who can join

Age: 12 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical diagnosis of Atopic Dermatitis for at least 3 months
• Investigator's Global Assessment (IGA) Score of 2 or 3
• Eczema Area Severity Index (EASI) score of 3-21
• Body Surface Area (BSA) of 2-20%
• Peak pruritus-Numerical Rating Scale (PPNRS) of Grade 2 or more

You may not qualify if…

• Other forms of dermatological diseases (other than atopic dermatitis)
• Fitzpatrick skin type score greater than 5
• Clinically significant abnormal ECG, vital signs, and laboratory values
• Infection with HBV, HCV, herpes zoster or tuberculosis

Where it is running

• Center for Dermatology and Plastic Surgery/CCT — Scottsdale, Arizona, United States
• Center for Dermatology and Plastic Surgery — Scottsdale, Arizona, United States
• California Dermatology & Clinical Research Institute — Encinitas, California, United States
• First OC Dermatology — Fountain Valley, California, United States
• Beach Allergy and Asthma Specialty Group, A Medical Corporation — Long Beach, California, United States
• Clinical Science Institute — Santa Monica, California, United States
• New England Associates, LLC — Bridgeport, Connecticut, United States
• Dermatology Physicians of Connecticut — Shelton, Connecticut, United States
• Yolanda C. Holmes, MD — Washington D.C., District of Columbia, United States
• Olympian Clinical Research — Clearwater, Florida, United States
• Accel Research Sites - DeLand Clinical Research Unit — DeLand, Florida, United States
• Jacksonville Center for Clinical Research — Jacksonville, Florida, United States
• Clinical Neuroscience Solutions, Inc. — Jacksonville, Florida, United States
• Precision Imaging — Jacksonville, Florida, United States
• Solutions Through Advanced Research, Inc — Jacksonville, Florida, United States
• Clinical Neuroscience Solutions, Inc. — Orlando, Florida, United States
• Leavitt Medical Associates of Florida d/b/a Ameriderm Research — Ormond Beach, Florida, United States
• Advanced Medical Research PC — Sandy Springs, Georgia, United States
• Sneeze, Wheeze & Itch Associates, LLC — Normal, Illinois, United States
• DS Research — New Albany, Indiana, United States
• DS Research — Louisville, Kentucky, United States
• Meridian Clinical Research, LLC — Baton Rouge, Louisiana, United States
• MediSearch Clinical Trials — Saint Joseph, Missouri, United States
• Dermatology Consulting Services, PLLC — High Point, North Carolina, United States
• Clinical Research Center of Alabama, LLC — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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