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

NCT ID: NCT06671834

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-22

Study Completion Date

2025-12-04

Brief Summary

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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:

* 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

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Conditions

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Acne Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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PF-07905428 Low Strength

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

Group Type EXPERIMENTAL

PF-07905428

Intervention Type DRUG

Topical solution of PF-07905428 0.08% or PF-07905428 0.24%

PF-07905428 High Strength

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

Group Type EXPERIMENTAL

PF-07905428

Intervention Type DRUG

Topical solution of PF-07905428 0.08% or PF-07905428 0.24%

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Topical solution of placebo

Interventions

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PF-07905428

Topical solution of PF-07905428 0.08% or PF-07905428 0.24%

Intervention Type DRUG

Placebo

Topical solution of placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Innovaderm Research Inc.

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=C5441001

To obtain contact information for a study center near you, click here.

Other Identifiers

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NCT06671834

Identifier Type: REGISTRY

Identifier Source: secondary_id

C5441001

Identifier Type: -

Identifier Source: org_study_id