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CompletedNCT04135560Updated May 14, 2020

A Study To Determine The Safety, Tolerability, Skin Irritation Potential, And PK Following Topical Application Of PF-07038124 In Healthy Participants

A Phase 1 interventional study of PF-07038124 and Vehicle and PF-07038124 or vehicle in Dermatitis Atopic, sponsored by Pfizer. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-14.

Sponsored by Pfizer · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Apr 2020, 6 years 5 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate the skin irritation potential of PF-07038124 ointment and vehicle (placebo) in Part A following multiple-doses applied topically to healthy participants. In Part B, the safety, tolerability, pharmacokinetic (PK), and skin irritation potential of PF-07038124 will be evaluated. In Part A, the highest concentration of 0.06% PF-07038124 will be applied to normal skin with a small surface area of 20 cm2 (0.1% body surface area [BSA]), while Part B will evaluate application of PF-07038124 and vehicle (placebo) to a surface area of 2000 cm2 (10% BSA) and 4000 cm2 (20% BSA). These data will provide support for clinical development in participants with mild to moderate AD.

02

Conditions studied

  • Dermatitis Atopic

Keywords

  • Eczema
03

In context

Dermatitis, Atopic

1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.

This study's enrollment of 34 is below the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Healthy female participants of non-childbearing potential and/or male participants who, at the time of screening, must be 18 to 55 years of age, inclusive, at the time of signing the informed consent document (ICD):
  2. Male and female participants who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
  3. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
  4. Participants enrolling as Japanese in Part B must have 4 biologically Japanese grandparents who were born in Japan.
  5. Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).

Exclusion criteria

Exclusion Criteria:

  1. Participants who have any visible skin damage or skin condition (eg sunburn, excessively deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, or other disfigurations) in or around the application site which, in the opinion of the investigative personnel, will interfere with the evaluation of the test site reaction.
  2. Participants who have a history of or have active AD/eczema/urticaria.
  3. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
  4. History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) or hepatitis C antibody (HCVAb). Hepatitis B vaccination is allowed.
  5. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
  6. Acute disease state (unstable medical condition such as nausea, vomiting, fever or diarrhea, etc) within 7 days of Day 1.
  7. Have undergone significant trauma or major surgery within 4 weeks of screening.
  8. Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of investigational product. (Refer to Section 6.5 for additional details).
  9. Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of investigational product used in this study (whichever is longer).
  10. A positive urine drug test.
  11. Screening supine blood pressure (BP) ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), following at least 5 minutes of supine rest. If BP is ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the participant's eligibility.
  12. Baseline 12-lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, baseline corrected QT (QTc) interval >450 msec, complete left bundle branch block [LBBB], signs of an acute or indeterminate-age myocardial infarction, ST-T interval changes suggestive of myocardial ischemia, second- or third-degree atrioventricular [AV] block, or serious bradyarrhythmias or tachyarrhythmias). If the baseline uncorrected QT interval is >450 msec, this interval should be rate-corrected using the Fridericia method and the resulting QTcF should be used for decision making and reporting. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more times and the average of the 3 QTc or QRS values should be used to determine the participant's eligibility. Computer-interpreted ECGs should be overread by a physician experienced in reading ECGs before excluding participants.
  13. Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study-specific laboratory and confirmed by a single repeat test, if deemed necessary:

    • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≥1.5 × upper limit of normal (ULN);
    • Total bilirubin level ≥1.5 × ULN; participants with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is ≤ ULN.
  14. History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening. Binge drinking is defined as a pattern of 5 (male) and 4 (female) or more alcoholic drinks in about 2 hours. As a general rule, alcohol intake should not exceed 14 units per week (1 unit = 8 ounces (240 mL) beer, 1 ounce (30 mL) of 40% spirit or 3 ounces (90 mL) of wine).
  15. Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
  16. History of serious adverse reactions or hypersensitivity to any topical drug; or known allergy to any of the test product(s) or any components in the test product(s) or history of hypersensitivity; or allergic reactions to any of the study preparations as described in the PF-07038124 IB.
  17. Not willing to refrain from shaving, the use of depilatories or other hair-removal activities, antiperspirants, lotions, skin creams, fragrances or perfumes, or body oils (eg, baby oil; coconut oil), use of hair products, hair gels, and hair oil in the treatment areas for 48 hours prior to admission to the CRU and for the duration of the stay in the CRU.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
34 participants (actual)

Study arms

  • Experimental
    Part A Cohort 1 (1% Body Surface Area)

    Each participant in this cohort will receive both PF-07038124 0.06% and vehicle applied to the skin (1% Body Surface Area)

    Drug: PF-07038124 and Vehicle

  • Experimental
    Part B Cohort 1 (10% Body Surface Area)

    Drug: PF-07038124 or vehicle

  • Experimental
    Part B Cohort 2 (10% Body Surface Area)

    Drug: PF-07038124 or vehicle

  • Experimental
    Part B Cohort 3 (10% Body Surface Area)

    Drug: PF-07038124 or vehicle

  • Experimental
    Part B Cohort 4 (10% Body Surface Area)

    Drug: PF-07038124 or vehicle

  • Experimental
    Part B Cohort 5 (20% Body Surface Area)

    Drug: PF-07038124 or vehicle

  • Experimental
    Part B Cohort 6 (10% Body Surface Area)

    Optional cohort of Japanese participants

    Drug: PF-07038124 or vehicle

Interventions

  • DrugPF-07038124 and Vehicle

    PF-07038124 0.06% and vehicle Ointment BID applied to 1% Body Surface Area (BSA)

  • DrugPF-07038124 or vehicle

    PF-07038124 0.01% or vehicle Ointment QD applied to 10% BSA

  • DrugPF-07038124 or vehicle

    PF-07038124 0.01% or vehicle Ointment BID applied to 10% BSA

  • DrugPF-07038124 or vehicle

    PF-07038124 0.03% or vehicle Ointment BID applied to 10% BSA

  • DrugPF-07038124 or vehicle

    PF-07038124 0.06% or vehicle ointment BID applied to 10% BSA

  • DrugPF-07038124 or vehicle

    PF-07038124 safe concentration or vehicle ointment BID applied to 20% BSA

  • DrugPF-07038124 or vehicle

    PF-07038124 safe concentration or vehicle BID applied to 10% BSA

06

What researchers measure

Primary outcomes

  1. Part A: Number of Participants with Treatment Emergent Treatment-Related Adverse Evenst (AEs)

    Incidence and severity of local and systemic treatment emergent AEs and withdrawals due to treatment emergent AEs

    Time frame: through study completion, up to 38 days

  2. Part A: Number of Adverse Events by Severity

    Incidence and severity of local and systemic treatment emergent AEs and withdrawals due to treatment emergent AEs

    Time frame: through study completion, up to 38 days

  3. Part B: Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)

    Assessment of AEs, safety laboratory tests, vital signs (including blood pressure, pulse rate and temperature), cardiac telemetry and 12-lead ECGs. Incidence and severity of local skin irritation.

    Time frame: through study completion, up to 41 days

  4. Part B: Number of Adverse Events by Severity

    Assessment of AEs, safety laboratory tests, vital signs (including blood pressure, pulse rate and temperature), cardiac telemetry and 12-lead ECGs. Incidence and severity of local skin irritation.

    Time frame: through study completion, up to 41 days

Secondary outcomes

  1. Part B: Maximum Observed Plasma Concentration (Cmax)

    Time frame: Days 1 and 10

  2. Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Time frame: Days 1 and 10

  3. Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)

    Time frame: Days 1 and 10

  4. Plasma Decay Half-Life (t1/2)

    Time frame: Days 1 and 10

  5. Average Concentration at Steady State (Cav)

    Time frame: Day 10

07

Study locations

1 site
  • Pfizer New Haven Clinical Research Unit
    New Haven, Connecticut 06511, United States
08

References and documents

Individual participant data

Plan to share: No — 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/data_requests.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 14, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04135560
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Oct 22, 2019
Start date
Oct 29, 2019
Primary completion
Apr 10, 2020
Completion
Apr 10, 2020
Last update
May 14, 2020

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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