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PF-07905428 for Acne
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 enrolling in Cohort 4 with acne vulgaris must have moderate to severe facial acne vulgaris
Be between 18 and 65 years old
Must not have
Participants with very severe acne
History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, approximately 2 months
Summary
This trial aims to test a new medicine (PF-07905428) for treating acne vulgaris. They are looking for participants aged 18-40 with moderate to severe acne. The medicine will
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 belowSelect...
I have moderate to severe acne on my face.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have very severe acne.
Select...
I have a history of HIV, hepatitis B, or hepatitis C.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, approximately 2 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, approximately 2 months
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 moreSecondary 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 moreTrial 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
4,675 Previous Clinical Trials
28,717,130 Total Patients Enrolled
3 Trials studying Acne Vulgaris
252 Patients Enrolled for Acne Vulgaris
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,556 Previous Clinical Trials
25,757,986 Total Patients Enrolled
3 Trials studying Acne Vulgaris
252 Patients Enrolled for Acne Vulgaris