PF-07905428 for Acne

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Pfizer

Disqualifiers: Very severe acne, Autoinflammatory syndromes, HIV, others

Trial Summary

What is the purpose of this trial?

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.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team to get a clear answer.

Eligibility Criteria

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.

Inclusion Criteria

I have mild to moderate acne on my face.

Participants who are overtly healthy as determined by medical evaluation

I have moderate to severe acne on my face.

See 1 more

Exclusion Criteria

Participants with autoinflammatory syndromes

I have a significant history of major health issues.

I have very severe acne.

See 2 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the study medicine applied daily on the face and/or back for 14 days (Cohorts 1 and 2) or 28 days (Cohorts 3 and 4)

2-4 weeks

17 visits (Cohorts 1 and 2) or 31 visits (Cohorts 3 and 4)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 call (phone)

Treatment Details

Interventions

PF-07905428 (Other)

Trial OverviewThe 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.

Participant Groups

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.