Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-26 @ 12:53 AM
Study NCT ID:
NCT06671834
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-18
First Post:
2024-10-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Learn About the Study Medicine Called PF-07905428 in Healthy Participants and Participants With Acne Vulgaris
Sponsor:
Pfizer
Organization:
Study Overview
Official Title:
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:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCT06671834 | REGISTRY | ClinicalTrials.gov | View |