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PF-07905428 High Strength for Acne Vulgaris

Phase 1
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, approximately 2 months
Awards & highlights
No Placebo-Only Group

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.

Who is the study for?
This trial is for men and women aged 18-40 who are generally healthy and have moderate to severe acne vulgaris. Participants will use the study medicine PF-07905428 or a placebo on their face/back daily for up to 28 days, with follow-up visits at the clinic.
What is being tested?
The trial tests PF-07905428's safety and effectiveness against acne vulgaris compared to a placebo. It involves daily application of the medication, regular clinic visits over approximately two months, and one follow-up phone call.
What are the potential side effects?
While specific side effects aren't listed here, common ones from topical acne treatments may include skin irritation, dryness, redness, peeling. The study aims to assess these potential reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, approximately 2 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, approximately 2 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants With Abnormalities in Vital Signs
Number of Participants With Clinical Laboratory Abnormalities
Number of Participants With Clinically Significant Changes From Baseline in 12-Lead Electrocardiogram (ECG) Parameters
+1 more
Secondary study objectives
Absolute change from baseline in inflammatory lesion counts (ILC)
Absolute change in non-inflammatory lesion counts (nILC)
Absolute change in total acne lesion counts
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: PF-07905428 Low StrengthExperimental Treatment1 Intervention
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 II: PF-07905428 High StrengthExperimental Treatment1 Intervention
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 III: PlaceboPlacebo Group1 Intervention
All participants will receive Placebo QD. Area of application will be increased as the study proceeds from one cohort to the next.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

PfizerLead Sponsor
4,651 Previous Clinical Trials
17,743,663 Total Patients Enrolled
3 Trials studying Acne Vulgaris
252 Patients Enrolled for Acne Vulgaris
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,538 Previous Clinical Trials
14,914,851 Total Patients Enrolled
3 Trials studying Acne Vulgaris
252 Patients Enrolled for Acne Vulgaris
~35 spots leftby Jul 2025
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