Study To Assess Efficacy, Safety, Tolerability And Pharmacokinetics Of PF-07038124 Ointment In Participants With Atopic Dermatitis Or Plaque Psoriasis
NCT ID: NCT04664153
Last Updated: 2022-08-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
104 participants
INTERVENTIONAL
2020-12-21
2021-08-18
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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atopic dermatitis - PF-07038124 ointment
PF-07038124 ointment
PF-07038124 ointment at 0.01% with QD dosing for 6 weeks
atopic dermatitis - vehicle ointment
Vehicle ointment
Vehicle ointment with QD dosing for 6 weeks
plaque psoriasis - PF-07038124 ointment
PF-07038124 ointment
PF-07038124 ointment at 0.01% with QD dosing for 6 weeks
plaque psoriasis - vehicle ointment
Vehicle ointment
Vehicle ointment with QD dosing for 6 weeks
Interventions
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PF-07038124 ointment
PF-07038124 ointment at 0.01% with QD dosing for 6 weeks
Vehicle ointment
Vehicle ointment with QD dosing for 6 weeks
Eligibility Criteria
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Inclusion Criteria
* Plaque psoriasis: Have been diagnosed with plaque psoriasis (psoriasis vulgaris) for at least 6 months; Have a Physician Global Assessment (PGA) score of 2 (mild), or 3 (moderate); Having plaque psoriasis covering 5% to 15% (inclusive) of BSA.
Exclusion Criteria
* Current or recent history of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiovascular, or neurological disease.
* Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
18 Years
70 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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First OC Dermatology
Fountain Valley, California, United States
Renaissance Research and Medical Group
Cape Coral, Florida, United States
Olympian Clinical Research
Clearwater, Florida, United States
Moonshine Research Center, Inc.
Doral, Florida, United States
Clinical Neuroscience Solutions
Orlando, Florida, United States
Center for Clinical Studies
Tampa, Florida, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, United States
Henry Ford Medical Center, New Center One
Detroit, Michigan, United States
M3 Wake Research, Inc.
Raleigh, North Carolina, United States
Oregon Dermatology and Research Center
Portland, Oregon, United States
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
Memphis, Tennessee, United States
studies in Dermatology, LLC
Cypress, Texas, United States
Center for Clinical Studies
Houston, Texas, United States
Center for Clinical Studies, LTD. LLP
Webster, Texas, United States
Australian Clinical Research Network
Maroubra, New South Wales, Australia
Emeritus Research
Camberwell, Victoria, Australia
Dermatrials Research Inc.
Hamilton, Ontario, Canada
Lynderm Research Inc.
Markham, Ontario, Canada
DermEdge Research
Mississauga, Ontario, Canada
Innovaderm Research Inc.
Montreal, Quebec, Canada
Centre de Recherche Dermatologique du Quebec metropolitain
Québec, , Canada
NZOZ Specjalistyczny Osrodek Dermatologiczny DERMAL
Bialystok, , Poland
Mazowieckie Centrum Badań Klinicznych
Grodzisk Mazowiecki, , Poland
Centrum Medyczne Angelius Provita
Katowice, , Poland
Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
Lodz, , Poland
Dermedic Jacek Zdybski
Ostrowiec Świętokrzyski, , Poland
Kliniczny Szpital Wojewódzki nr 1 im. F. Chopina w Rzeszowie
Rzeszów, , Poland
ETG Warszawa
Warsaw, , Poland
Countries
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References
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Eichenfield LF, Tarabar S, Forman S, Garcia-Bello A, Feng G, Fetterly G, Mahling P, Peeva E, Vincent MS, Chandra DE. Efficacy and Safety of PF-07038124 in Patients With Atopic Dermatitis and Plaque Psoriasis: A Randomized Clinical Trial. JAMA Dermatol. 2024 Feb 1;160(2):156-163. doi: 10.1001/jamadermatol.2023.4990.
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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2020-003977-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
C3941002
Identifier Type: -
Identifier Source: org_study_id
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