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Completed

NCT Number: NCT06671834

A Study to Learn About the Study Medicine Called PF-07905428 in Healthy Participants and Participants With Acne Vulgaris

The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-07905428) for the potential treatment of acne vulgaris.

This study is seeking participants who:

* Are male or female between the ages of 18 and 40 * Are generally healthy * Are diagnosed with moderate to severe acne vulgaris (Cohort 4 only)

The study medicine will be applied every day on the participant's face and/or back for 14 days (Cohorts 1 and 2) or for 28 days (Cohort 3 and 4).

The investigators will compare the experiences of people receiving the study medicine to those of the people who do not. This will help the investigators determine if the study medicine is safe and effective.

Participants will take part in this study for approximately 2 months. During this time, they will have 17 study visits (Cohorts 1 and 2) or 31 study visits (Cohorts 3 and 4) at the study clinic. The study team will also call participants once at the end of the study over the phone.

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Innovaderm Research Inc.

Montreal, Quebec, H2X 2V1, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants who are overtly healthy as determined by medical evaluation.
  • Only for participants who are enrolling with acne vulgaris: diagnosis of acne vulgaris for 3 months or greater
  • For participants enrolling in Cohort 1-3 with acne vulgaris (optional): mild to moderate facial acne vulgaris
  • For participants enrolling in Cohort 4 with acne vulgaris: moderate to severe facial acne vulgaris

Exclusion criteria

  • Participants with very severe acne
  • Participants with autoinflammatory syndromes
  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease
  • History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C.
  • Participants with clinically significant laboratory abnormalities

Treatment and study plan

PF-07905428

Drug

Topical solution of PF-07905428 0.08% or PF-07905428 0.24%

Placebo

Drug

Topical solution of placebo

Primary outcomes

  1. Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Time frame: Through study completion, approximately 2 months

    An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were events between first dose of study drug and up to 37 days after last dose that were absent before treatment or that worsened relative to pretreatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs included SAEs and all non-SAEs that occurred during the study.

  2. Number of Participants With Clinical Laboratory Abnormalities

    Time frame: Through study completion, approximately 2 months

    Evaluation of participants with clinically meaningful changes from baseline in laboratory test results

  3. Number of Participants With Abnormalities in Vital Signs

    Time frame: Through study completion, approximately 2 months

    Any untoward vital sign findings that are identified during the active collection period and meet the definition of an AE or SAE.

  4. Number of Participants With Clinically Significant Changes From Baseline in 12-Lead Electrocardiogram (ECG) Parameters

    Time frame: Through study completion, approximately 2 months

    12-lead ECG were performed after the participant had rested quietly for at least 10 minutes in a supine position. ECG parameters included RR interval, PR interval, QRS complex, QT interval, corrected QT (QTc) interval, Bazett's correction QT (QTcB) interval, Heart Rate and Fridericia's correction (QTcF) interval. Clinical significance of 12-Lead ECG was judged by investigator.

Secondary outcomes

  1. Maximum plasma concentration (Cmax) of PF-07905428

    Time frame: Day 14 (Cohorts 1, 2, and 4) Day 28 (Cohorts 3 and 4)

  2. Time to maximum plasma concentration (Tmax) of PF-07905428

    Time frame: Day 14 (Cohorts 1, 2, and 4) Day 28 (Cohorts 3 and 4)

  3. Area Under the Serum Concentration-Time Curve Over the Dosing Interval (AUCtau) of PF-07905428

    Time frame: Day 14 (Cohorts 1, 2, and 4) Day 28 (Cohorts 3 and 4)

    Area under the plasma concentration-time curve from time 0 to the end of the dosing interval (AUCtau)

  4. Terminal serum elimination half life (t1/2) of PF-07905428

    Time frame: Day 14 (Cohorts 1, 2, and 4) Day 28 (Cohorts 3 and 4)

  5. Absolute change in total acne lesion counts

    Time frame: Baseline to Week 4

    To compare the clinical effect of PF-07905428 versus placebo on absolute change from baseline in total lesion count (TLC) in participants with moderate to severe acne vulgaris.

  6. Absolute change from baseline in inflammatory lesion counts (ILC)

    Time frame: Baseline to Week 4

    To compare the clinical effect of PF-07905428 versus placebo on absolute change from baseline in inflammatory lesion counts (ILC) in participants with moderate to severe acne vulgaris.

  7. Absolute change in non-inflammatory lesion counts (nILC)

    Time frame: Baseline to Week 4

    To compare the clinical effect of PF-07905428 versus placebo on absolute change from baseline in non-inflammatory lesion counts (nILC) in participants with moderate to severe acne vulgaris.

  8. Percentage of Participants who achieve Investigator global assessment (IGA) of 0 or 1

    Time frame: Baseline to Week 4

    Percentage of participants who achieve IGA score of "clear" or "almost clear" on the face (modified IGA of 0 or 1) with 2-points or greater improvement at Week 4 compared to placebo.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED, DOSE ESCALATION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF MULTIPLE-DOSE TOPICAL ADMINISTRATION OF PF-07905428 IN HEALTHY PARTICIPANTS AND PARTICIPANTS WITH ACNE VULGARIS, AND ADDITIONALLY CLINICAL EFFECT IN PARTICIPANTS WITH MODERATE TO SEVERE ACNE VULGARIS AGED 18 TO 40 YEARS OLD

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 4, 2024
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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