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

Phase 1

Recruiting

• Conditions: Acne Vulgaris
• Interventions: Drug: PF-07905428; Drug: Placebo

• Registration Number: NCT06671834
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2024-10-18
• Study First Submitted QC: 2024-10-31
• Study First Posted: 2024-11-04
• Study Start: 2024-11-22
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-19
• Last Update Posted: 2024-12-24
• Primary Completion: 2025-09-20
• Study Completion: 2025-09-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 52

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PF-07905428 Low Strength	PF-07905428	Participants may receive 0.08% PF-07905428 QD. Area of application will be increased as the study proceeds from one cohort to the next.
PF-07905428 High Strength	PF-07905428	Participants may receive 0.24% PF-07905428 QD. Area of application will be increased as the study proceeds from one cohort to the next.
Placebo	Placebo	All participants will receive Placebo QD. Area of application will be increased as the study proceeds from one cohort to the next.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	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.
Number of Participants With Clinical Laboratory Abnormalities	Through study completion, approximately 2 months	Evaluation of participants with clinically meaningful changes from baseline in laboratory test results
Number of Participants With Abnormalities in Vital Signs	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.
Number of Participants With Clinically Significant Changes From Baseline in 12-Lead Electrocardiogram (ECG) Parameters	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 Outcome Measures

Name	Time	Method
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)	Area under the plasma concentration-time curve from time 0 to the end of the dosing interval (AUCtau)
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	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.
Absolute change from baseline in inflammatory lesion counts (ILC)	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.
Absolute change in non-inflammatory lesion counts (nILC)	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.
Percentage of Participants who achieve Investigator global assessment (IGA) of 0 or 1	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.

Trial Locations

Locations (2)

InnovaDerm; 🇨🇦 Montreal, Quebec, Canada

Innovaderm Research Inc.; 🇨🇦 Montréal, Quebec, Canada