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| ID | Type | Description | Link |
|---|---|---|---|
| NCT06671834 | Registry Identifier | ClinicalTrials.gov |
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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-07905428 | Drug | Topical solution of PF-07905428 0.08% or PF-07905428 0.24% |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Innovaderm Research Inc. | Montreal | Quebec | H2X 2V1 | Canada |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| Placebo | Drug | Topical solution of placebo |
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| 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) | 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 | 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. | 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. | 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. | 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. | Baseline to Week 4 |