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

NCT06671834 | Completed Phase 1 FDA Drug

• 2 other identifiers: C5441001NCT06671834
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (4)

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

  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.

  Through study completion, approximately 2 months

• Number of Participants With Clinical Laboratory Abnormalities

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

  Through study completion, approximately 2 months

• Number of Participants With Abnormalities in Vital Signs

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

  Through study completion, approximately 2 months

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

  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.

  Through study completion, approximately 2 months

Secondary Outcomes (8)

• Maximum plasma concentration (Cmax) of PF-07905428

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

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

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

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

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

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

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

• Absolute change in total acne lesion counts

  Baseline to Week 4

Study Arms (3)

PF-07905428 Low Strength

EXPERIMENTAL

Participants may receive 0.08% PF-07905428 QD. Area of application will be increased as the study proceeds from one cohort to the next.

Drug: PF-07905428

PF-07905428 High Strength

EXPERIMENTAL

Participants may receive 0.24% PF-07905428 QD. Area of application will be increased as the study proceeds from one cohort to the next.

Drug: PF-07905428

Placebo

PLACEBO COMPARATOR

All participants will receive Placebo QD. Area of application will be increased as the study proceeds from one cohort to the next.

Drug: Placebo

Interventions

PF-07905428 DRUG

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

PF-07905428 High Strength; PF-07905428 Low Strength

Placebo DRUG

Topical solution of placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Innovaderm Research Inc.

Montreal, Quebec, H2X 2V1, Canada

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: November 4, 2024
• Study Start: November 22, 2024
• Primary Completion: December 4, 2025
• Study Completion: December 4, 2025
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)