Study To Assess Efficacy, Safety, Tolerability And Pharmacokinetics Of PF-07038124 Ointment In Participants With Atopic Dermatitis Or Plaque Psoriasis

NCT04664153

Last updated date
Study Location
First OC Dermatology
Fountain Valley, California, 92708, United States
Contact
1-800-718-1021

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Atopic Dermatitis, Plaque Psoriasis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Atopic Dermatitis (AD): Have been diagnosed with AD for at least 3 months; Have an Investigator's Global Assessment (IGA) score of 2 (mild), or 3 (moderate); Have AD covering 5% to 20% (inclusive) of BSA.

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Presence of skin comorbidities that would interfere with study assessment or response
to treatment.


- 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.

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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

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[email protected]

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Atopic Dermatitis, Plaque PsoriasisStudy To Assess Efficacy, Safety, Tolerability And Pharmacokinetics Of PF-07038124 Ointment In Participants With Atopic Dermatitis Or Plaque Psoriasis
NCT04664153
  1. Fountain Valley, California
  2. Clearwater, Florida
  3. Raleigh, North Carolina
  4. Carlton, Victoria
  5. East Melbourne, Victoria
  6. Montréal, Quebec
  7. Bialystok,
  8. Grodzisk Mazowiecki,
  9. Katowice,
  10. Lodz,
  11. Ostrowiec Swietokrzyski,
  12. Rzeszow,
  13. Warszawa,
  14. Glendale, Arizona
  15. Cape Coral, Florida
  16. Doral, Florida
  17. Miami, Florida
  18. Orlando, Florida
  19. Tampa, Florida
  20. Indianapolis, Indiana
  21. Plainfield, Indiana
  22. Detroit, Michigan
  23. Portland, Oregon
  24. Memphis, Tennessee
  25. Cypress, Texas
  26. Houston, Texas
  27. Webster, Texas
  28. Maroubra, New South Wales
  29. Camberwell, Victoria
  30. Hamilton, Ontario
  31. Markham, Ontario
  32. Mississauga, Ontario
  33. Peterborough, Ontario
  34. Quebec,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study To Assess Efficacy, Safety, Tolerability And Pharmacokinetics Of PF-07038124 Ointment In Participants With Atopic Dermatitis Or Plaque Psoriasis
Official Title  ICMJE A PHASE 2A, RANDOMIZED, DOUBLE BLIND, VEHICLE CONTROLLED, PARALLEL GROUP STUDY TO ASSESS THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-07038124 OINTMENT FOR 6 WEEKS IN PARTICIPANTS WITH MILD TO MODERATE ATOPIC DERMATITIS OR PLAQUE PSORIASIS
Brief Summary This study is being conducted to provide data on efficacy, safety, tolerability and PK of PF-07038124 ointment versus vehicle control in the treatment of mild to moderate AD and mild to moderate plaque psoriasis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Atopic Dermatitis
  • Plaque Psoriasis
Intervention  ICMJE
  • Drug: PF-07038124 ointment
    PF-07038124 ointment at 0.01% with QD dosing for 6 weeks
  • Drug: Vehicle ointment
    Vehicle ointment with QD dosing for 6 weeks
Study Arms  ICMJE
  • Experimental: atopic dermatitis - PF-07038124 ointment
    Intervention: Drug: PF-07038124 ointment
  • Placebo Comparator: atopic dermatitis - vehicle ointment
    Intervention: Drug: Vehicle ointment
  • Experimental: plaque psoriasis - PF-07038124 ointment
    Intervention: Drug: PF-07038124 ointment
  • Experimental: plaque psoriasis - vehicle ointment
    Intervention: Drug: Vehicle ointment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 6, 2020)
88
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 6, 2021
Estimated Primary Completion Date December 6, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Atopic Dermatitis (AD): Have been diagnosed with AD for at least 3 months; Have an Investigator's Global Assessment (IGA) score of 2 (mild), or 3 (moderate); Have AD covering 5% to 20% (inclusive) of BSA.
  • 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:

  • Presence of skin comorbidities that would interfere with study assessment or response to treatment.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE Australia,   Canada,   Poland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04664153
Other Study ID Numbers  ICMJE C3941002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP