A Study to Learn About The Study Medicine (PF-07038124) In Patients With Mild To Moderate Atopic Dermatitis Or Mild To Severe Plaque Psoriasis.
Public ClinicalTrials.gov record NCT05375955. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A PHASE 2B, RANDOMIZED, DOUBLE BLIND, VEHICLE CONTROLLED, PARALLEL GROUP STUDY TO ASSESS THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF MULTIPLE DOSE LEVELS OF PF-07038124 OINTMENT FOR 12 WEEKS IN PARTICIPANTS 12 YEARS AND OLDER AND WITH MILD-TO-MODERATE ATOPIC DERMATITIS OR MILD-TO-SEVERE PLAQUE PSORIASIS
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05375955
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 263 participants
Conditions and interventions
Conditions
Interventions
- PF-07038124 ointment 0.01% Drug
- Vehicle ointment Drug
- PF-07038124 ointment 0.03% Drug
- PF-07038124 ointment 0.06% Drug
Drug
Eligibility (public fields only)
- Age range
- 12 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 26, 2022 (Actual)
- Primary completion
- Jul 31, 2023 (Actual)
- Completion
- Jul 31, 2023 (Actual)
- Last update posted
- Oct 2, 2024
2022 – 2023
United States locations
- U.S. sites
- 23
- U.S. states
- 14
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| California Dermatology & Clinical Research Institute | Encinitas | California | 92024 | — |
| USC/Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | — |
| Renaissance Research and Medical Group | Cape Coral | Florida | 33991 | — |
| Clinical Neuroscience Solutions, Inc. dba CNS Healthcare | Jacksonville | Florida | 32256 | — |
| ForCare Clinical Research | Tampa | Florida | 33613 | — |
| Skin Care Physicians of Georgia | Macon | Georgia | 31217 | — |
| Sneeze, Wheeze & Itch Associates, LLC | Normal | Illinois | 61761 | — |
| Dawes Fretzin Clinical Research Group, LLC | Indianapolis | Indiana | 46250 | — |
| Velocity Clinical Research at The Dermatology Clinic, Baton Rouge | Baton Rouge | Louisiana | 70808 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Wayne Health | Dearborn | Michigan | 48124 | — |
| Northwell Health Clinical Trials Office | Lake Success | New York | 11042 | — |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10028 | — |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | — |
| Vital Prospects Clinical Research Institute, PC | Tulsa | Oklahoma | 74136 | — |
| Velocity Clinical Research, Medford | Medford | Oregon | 97504 | — |
| Health Concepts | Rapid City | South Dakota | 57702 | — |
| Clinical Neuroscience Solutions Inc. | Memphis | Tennessee | 38119 | — |
| Clinical Neuroscience Solutions, Inc. dba CNS Healthcare | Memphis | Tennessee | 38119 | — |
| Dermatology Treatment and Research Center | Dallas | Texas | 75230 | — |
| Progressive Clinical Research | San Antonio | Texas | 78213 | — |
| Texas Dermatology and Laser Specialists | San Antonio | Texas | 78218 | — |
| Virginia Clinical Research, Inc. | Norfolk | Virginia | 23502 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 16 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05375955, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 2, 2024 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05375955 live on ClinicalTrials.gov.