A Study to Learn About The Study Medicine (PF-07038124) In Patients With Mild To Moderate Atopic Dermatitis Or Mild To Severe Plaque Psoriasis.

Study Purpose

The purpose of this clinical trial is to learn about the safety, how well the study medicine works, extent to which side effects can be tolerated, and how the study medicine is changed and eliminated from your body after you apply it on your skin. The study medicine is in ointment form. This study is seeking participants who. If they have Atopic Dermatitis (AD):

  • - Have a diagnosis for at least 3 months.
  • - Have a diagnosis of mild or moderate disease assessed using Investigator's Global Assessment (IGA) - Have percent Body Surface Area (%BSA) covering 5% up to 40% - A Peak Pruritus Numerical Rating Scale (PP-NRS) average score of ≥2 during the screening period.
If they have plaque psoriasis (PsO):
  • - Have a diagnosis for at least 6 months.
  • - Have a diagnosis of mild, moderate, or severe disease assessed using Physician's Global Assessment (PGA) - Have percent Body Surface Area (%BSA) covering 2% up to 20% All participants in this study will receive either 0.01% PF-07038124, 0.03% PF-07038124, or a vehicle ointment.
In addition, some participants with PsO will receive 0.06% PF- PF-07038124. Participants will not know which dose level they have received. The participants will be randomly assigned to each dose group. PF-07038124 ointment will be applied topically to affected areas once daily. We will compare the experiences of people receiving the different dose levels of the ointment to those who receive the vehicle ointment. This will help us determine if PF-07038124 ointment is safe and effective. Participants will take part in this study for approximately 21 weeks. Participants will apply the study medicine once daily for 12 weeks followed by a safety follow-up period of 4-5 weeks from last application of study medicine to last visit.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 12 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria for AD population:

  • - Diagnosis of Atopic Dermatitis (AD) for at least 3 months.
  • - Investigator's Global Assessment (IGA) score of 2 (mild), or 3 (moderate) - AD covering 5% and up to 40% of Body Surface Area (BSA) - A Peak Pruritus Numerical Rating Scale (PP-NRS) average score of ≥2.
Inclusion Criteria for Plaque Psoriasis.
  • - Diagnosis of Plaque Psoriasis (PsO) for at least 6 months.
  • - Physician Global Assessment (PGA) score of 2 (mild), 3 (moderate), or 4 (severe) - PsO covering 2% to 20% (inclusive) of BSA.

Exclusion Criteria:

  • - Presence of skin comorbidities that would interfere with study assessment or response to treatment.
  • - Psychiatric condition including recent or active suicidal ideation or behavior.
  • - Current or recent history of severe, progressive, or uncontrolled disease.
  • - A history of systemic, chronic or acute skin infection requiring hospitalization, parenteral antimicrobial therapy, or is judged clinically significant.
  • - Recent, significant trauma or major surgery.
  • - History of cancer or have undergone treatment for any type of cancer, with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ with no evidence of recurrence.
  • - History of angioedema or anaphylaxis to topical products or known sensitivity to any of the components of the investigational products.
  • - Use of any prohibited concomitant medication(s) - Previous administration with an investigational drug within 30 days or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer).
  • - Participants with an estimated glomerular filtration rate (eGFR) of <40 mL/min/1.73m2 calculated using the serum creatinine-based Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) formula for adults and serum creatinine >1.5 x upper limit of normal (ULN) in adolescents (12-18 years old) - Participants with total bilirubin ≥2x ULN (≥3 x ULN for Gilbert's disease), aspartate aminotransferase (AST) ≥2.5 x ULN, ALT ≥2.5 x ULN.
  • - Clinically relevant abnormal baseline standard 12-lead electrocardiogram (ECG) including, but not limited to QTC corrected using Fridericia's Formula (QTcF) interval >450 msec and QRS > 120 msec.
- A recent history of alcohol or substance abuse

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05375955
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Pfizer
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Pfizer CT.gov Call Center
Principal Investigator Affiliation Pfizer
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Active, not recruiting
Countries Canada, Japan, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Atopic Dermatitis, Plaque Psoriasis
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Atopic Dermatitis PF-07038124 0.01% ointment

Atopic Dermatitis

Placebo Comparator: Atopic Dermatitis Vehicle ointment

Atopic Dermatitis

Experimental: Atopic Dermatitis PF-07038124 0.03% ointment

Atopic Dermatitis

Experimental: Plaque Psoriasis PF-07038124 0.01% ointment

Plaque Psoriasis

Experimental: Plaque Psoriasis PF-07038124 0.03% ointment

Plaque Psoriasis

Experimental: Plaque Psoriasis PF-07038124 0.06% ointment

Plaque Psoriasis

Placebo Comparator: Plaque Psoriasis Vehicle ointment

Plaque Psoriasis

Interventions

Drug: - PF-07038124 ointment 0.01%

Atopic Dermatitis and Plaque Psoriasis

Drug: - Vehicle ointment

Atopic Dermatitis and Plaque Psoriasis

Drug: - PF-07038124 ointment 0.03%

Atopic Dermatitis and Plaque Psoriasis

Drug: - PF-07038124 ointment 0.06%

PF-07038124 ointment 0.06% (Plaque Psoriasis only)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Encinitas, California

Status

Address

California Dermatology & Clinical Research Institute

Encinitas, California, 92024

USC/Norris Comprehensive Cancer Center, Los Angeles, California

Status

Address

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033

Renaissance Research and Medical Group, Cape Coral, Florida

Status

Address

Renaissance Research and Medical Group

Cape Coral, Florida, 33991

Jacksonville, Florida

Status

Address

Clinical Neuroscience Solutions, Inc. dba CNS Healthcare

Jacksonville, Florida, 32256

ForCare Clinical Research, Tampa, Florida

Status

Address

ForCare Clinical Research

Tampa, Florida, 33613

Skin Care Physicians of Georgia, Macon, Georgia

Status

Address

Skin Care Physicians of Georgia

Macon, Georgia, 31217

Sneeze, Wheeze & Itch Associates, LLC, Normal, Illinois

Status

Address

Sneeze, Wheeze & Itch Associates, LLC

Normal, Illinois, 61761

Indianapolis, Indiana

Status

Address

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46250

Baton Rouge, Louisiana

Status

Address

Velocity Clinical Research at The Dermatology Clinic, Baton Rouge

Baton Rouge, Louisiana, 70808

University of Michigan, Ann Arbor, Michigan

Status

Address

University of Michigan

Ann Arbor, Michigan, 48109

Wayne Health, Dearborn, Michigan

Status

Address

Wayne Health

Dearborn, Michigan, 48124

Northwell Health Clinical Trials Office, Lake Success, New York

Status

Address

Northwell Health Clinical Trials Office

Lake Success, New York, 11042

Icahn School of Medicine at Mount Sinai, New York, New York

Status

Address

Icahn School of Medicine at Mount Sinai

New York, New York, 10028

Icahn School of Medicine at Mount Sinai, New York, New York

Status

Address

Icahn School of Medicine at Mount Sinai

New York, New York, 10029

Tulsa, Oklahoma

Status

Address

Vital Prospects Clinical Research Institute, PC

Tulsa, Oklahoma, 74136

Velocity Clinical Research, Medford, Medford, Oregon

Status

Address

Velocity Clinical Research, Medford

Medford, Oregon, 97504

Health Concepts, Rapid City, South Dakota

Status

Address

Health Concepts

Rapid City, South Dakota, 57702

Clinical Neuroscience Solutions Inc., Memphis, Tennessee

Status

Address

Clinical Neuroscience Solutions Inc.

Memphis, Tennessee, 38119

Memphis, Tennessee

Status

Address

Clinical Neuroscience Solutions, Inc. dba CNS Healthcare

Memphis, Tennessee, 38119

Dallas, Texas

Status

Address

Dermatology Treatment and Research Center

Dallas, Texas, 75230

Progressive Clinical Research, San Antonio, Texas

Status

Address

Progressive Clinical Research

San Antonio, Texas, 78213

Texas Dermatology and Laser Specialists, San Antonio, Texas

Status

Address

Texas Dermatology and Laser Specialists

San Antonio, Texas, 78218

Virginia Clinical Research, Inc., Norfolk, Virginia

Status

Address

Virginia Clinical Research, Inc.

Norfolk, Virginia, 23502

International Sites

Dermatology Research Institute, Calgary, Alberta, Canada

Status

Address

Dermatology Research Institute

Calgary, Alberta, T2J 7E1

Wiseman Dermatology Research Inc., Winnipeg, Manitoba, Canada

Status

Address

Wiseman Dermatology Research Inc.

Winnipeg, Manitoba, R3M 3Z4

Lynderm Research Inc., Markham, Ontario, Canada

Status

Address

Lynderm Research Inc.

Markham, Ontario, L3P 1X3

DermEdge Research, Mississauga, Ontario, Canada

Status

Address

DermEdge Research

Mississauga, Ontario, L4Y 4C5

SKiN Centre for Dermatology, Peterborough, Ontario, Canada

Status

Address

SKiN Centre for Dermatology

Peterborough, Ontario, K9J 5K2

Innovaderm Research Inc., Montréal, Quebec, Canada

Status

Address

Innovaderm Research Inc.

Montréal, Quebec, H2X 2V1

Quebec, Canada

Status

Address

Centre de Recherche Dermatologique du Quebec metropolitain

Quebec, , G1V 4X7

Takagi Dermatological Clinic Branch, Obihiro, Hokkaido, Japan

Status

Address

Takagi Dermatological Clinic Branch

Obihiro, Hokkaido, 080-0013

Takagi Dermatology, Obihiro, Hokkaido, Japan

Status

Address

Takagi Dermatology

Obihiro, Hokkaido, 080-0013

Dermatology Shimizu Clinic, Kobe, Hyogo, Japan

Status

Address

Dermatology Shimizu Clinic

Kobe, Hyogo, 657-0846

Sakai City, Osaka, Japan

Status

Address

Dermatology and Ophthalmology Kume Clinic

Sakai City, Osaka, 593-8324

Shirasaki dermatology clinic, Takaoka, Toyama, Japan

Status

Address

Shirasaki dermatology clinic

Takaoka, Toyama, 933-0871

Egin Research High Wycombe, High Wycombe, Buckinghamshire, United Kingdom

Status

Address

Egin Research High Wycombe

High Wycombe, Buckinghamshire, HP11 2QW

Southampton General Hospital, Southampton, Hampshire, United Kingdom

Status

Address

Southampton General Hospital

Southampton, Hampshire, SO16 6YD

Accellacare - North London, Northwood, London, CITY OF, United Kingdom

Status

Address

Accellacare - North London

Northwood, London, CITY OF, HA6 2RN

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.