NCT06671834

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

A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED, DOSE ESCALATION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF MULTIPLE-DOSE TOPICAL ADMINISTRATION OF PF-07905428 IN HEALTHY PARTICIPANTS AND PARTICIPANTS WITH ACNE VULGARIS, AND ADDITIONALLY CLINICAL EFFECT IN PARTICIPANTS WITH MODERATE TO SEVERE ACNE VULGARIS AGED 18 TO 40 YEARS OLD

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	PF-07905428	Topical solution of PF-07905428 0.08% or PF-07905428 0.24%
DRUG	Placebo	Topical solution of placebo

Timeline

• Start date: 2024-11-22
• Primary completion: 2025-12-04
• Completion: 2025-12-04
• First posted: 2024-11-04
• Last updated: 2025-12-30

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study