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

Pfizer

Status and phase: Enrolling; Phase 1

Conditions: Acne Vulgaris

Treatments: Drug: PF-07905428; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06671834

NCT06671834 (Registry Identifier)

C5441001

Details and patient eligibility

About

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.

Enrollment: 52 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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52 participants in 3 patient groups, including a placebo group

PF-07905428 Low Strength

Experimental group

Description:

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

Treatment:

Drug: PF-07905428

PF-07905428 High Strength

Experimental group

Description:

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

Treatment:

Drug: PF-07905428

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo