Dose Ranging Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of PF-06700841 Topical Cream in Participants With Mild or Moderate Atopic Dermatitis
NCT ID: NCT03903822
Last Updated: 2021-03-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
292 participants
INTERVENTIONAL
2019-05-13
2020-05-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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PF-06700841 0.1% cream QD
PF-06700841 0.1% cream applied once daily (QD)
PF-06700841
PF-06700841 topical cream
PF-06700841 0.3% cream QD
PF-06700841 0.3% cream applied once daily (QD)
PF-06700841
PF-06700841 topical cream
PF-06700841 1% cream QD
PF-06700841 1% cream applied once daily (QD)
PF-06700841
PF-06700841 topical cream
PF-06700841 3% cream QD
PF-06700841 3% cream applied once daily (QD)
PF-06700841
PF-06700841 topical cream
PF-06700841 0.3% cream BID
PF-06700841 0.3% cream applied twice daily (BID)
PF-06700841
PF-06700841 topical cream
PF-06700841 1% cream BID
PF-06700841 1% cream applied twice daily (BID)
PF-06700841
PF-06700841 topical cream
Vehicle cream QD
Vehicle cream applied once daily (QD)
Vehicle (Placebo)
Vehicle topical cream
Vehicle cream BID
Vehicle cream applied twice daily (BID)
Vehicle (Placebo)
Vehicle topical cream
Interventions
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PF-06700841
PF-06700841 topical cream
Vehicle (Placebo)
Vehicle topical cream
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Fitzpatrick skin type score greater than 5
* Clinically significant abnormal ECG, vital signs, and laboratory values
* Infection with HBV, HCV, herpes zoster or tuberculosis
12 Years
75 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Clinical Research Center of Alabama, LLC
Birmingham, Alabama, United States
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
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Vital Prospects Clinical Research Institute, PC
Tulsa, Oklahoma, United States
Health Concepts
Rapid City, South Dakota, United States
Tanenbaum Dermatology Center
Memphis, Tennessee, United States
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, United States
studies in Dermatology, LLC
Cypress, Texas, United States
Center for Clinical Studies, LTD.LLP
Houston, Texas, United States
Ventavia Research Group LLC
Hurst, Texas, United States
Center for Clinical Studies, LTD. LLP
Webster, Texas, United States
Summit Clinical Research, LLC
Franklin, Virginia, United States
Virginia Dermatology and Skin Cancer Center
Norfolk, Virginia, United States
Australian Clinical Research Network
Maroubra, New South Wales, Australia
Emeritus Research
Camberwell, Victoria, Australia
Sinclair Dermatology
East Melbourne, Victoria, Australia
Cabrini Hospital
Malvern, Victoria, Australia
Center for Skin and Venereal Diseases EOOD - Sofia
Sofia, , Bulgaria
DCC Alexandrovska
Sofia, , Bulgaria
Diagnostic Consultative Center - Fokus-5 - Medical Establishment for Outpatient Care OOD
Sofia, , Bulgaria
Wiseman Dermatology Research Inc.
Winnipeg, Manitoba, Canada
SKiN Health
Cobourg, Ontario, Canada
Innovaderm Research Inc.
Montreal, Quebec, Canada
Diex Recherche Sherbrooke Inc.
Sherbrooke, Quebec, Canada
Gentofte Hospital
Hellerup, , Denmark
Emovis GmbH
Berlin, , Germany
Rothhaar Studien GmbH
Berlin, , Germany
ISA - Interdisciplinary Study Association GmbH
Berlin, , Germany
Klinikum Bielefeld gem.GmbH
Bielefeld, , Germany
Universitätsklinikum Bonn AöR
Bonn, , Germany
Universitätsklinikum Frankfurt
Frankfurt, , Germany
MENSINGDERMA research GmbH
Hamburg, , Germany
MVZ Alstermed GmbH
Hamburg, , Germany
Dermatologische Gemeinschaftspraxis
Mahlow, , Germany
Klinische Forschung Schwerin GmbH
Schwerin, , Germany
Semmelweis Egyetem Altalanos Orvostudomanyi Kar
Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, , Hungary
Bacs-Kiskun Megyei Korhaz Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Oktato Korhaza
Kecskemét, , Hungary
CRU Hungary Kft.
Miskolc, , Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Szeged, , Hungary
Kitago Dermatology Clinic
Sapporo, Hokkaido, Japan
Nakatsuhifuka Clinic
Kita-ku, Osaka-shi, Osaka, Japan
Parkside Hiroo Ladies Clinic
Minato-ku, Tokyo, Japan
Tanpopo Skin Clinic
Ōta-ku, Tokyo, Japan
Shinjuku Minamiguchi Dermatology Skin Clinic
Shinjuku-ku, Tokyo, Japan
Medical Corporation Jitai-kai Tachikawa Dermatology Clinic
Tachikawa, Tokyo, Japan
Aesthetic dermatology clinic of Prof. J. Kisis
Riga, , Latvia
Health and Aesthetics Ltd
Riga, , Latvia
Outpatient Clinic of Ventspils
Ventspils, , Latvia
NZOZ Specjalistyczny Ośrodek Dermatologiczny DERMAL s.c.
Bialystok, , Poland
NASZ LEKARZ Przychodnie Medyczne
Torun, , Poland
MTZ Clinical Research Sp. z o.o
Warsaw, , Poland
WroMedica I. Bielicka, A. Strzalkowska s.c.
Wroclaw, , Poland
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2018-003050-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
B7931022
Identifier Type: -
Identifier Source: org_study_id
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