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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
52
Topical solution of PF-07905428 0.08% or PF-07905428 0.24%
Topical solution of placebo
Innovaderm Research Inc.
Montreal, Quebec, Canada
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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Through study completion, approximately 2 months
Maximum plasma concentration (Cmax) of PF-07905428
Time frame: Day 14 (Cohorts 1, 2, and 4) Day 28 (Cohorts 3 and 4)
Time to maximum plasma concentration (Tmax) of PF-07905428
Time frame: 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
Area under the plasma concentration-time curve from time 0 to the end of the dosing interval (AUCtau)
Time frame: Day 14 (Cohorts 1, 2, and 4) Day 28 (Cohorts 3 and 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)
Absolute change in total acne lesion counts
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.
Time frame: Baseline to Week 4
Absolute change from baseline in inflammatory lesion counts (ILC)
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.
Time frame: Baseline to Week 4
Absolute change in non-inflammatory lesion counts (nILC)
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.
Time frame: Baseline to Week 4
Percentage of Participants who achieve Investigator global assessment (IGA) of 0 or 1
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.
Time frame: Baseline to Week 4
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.