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: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 40
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Canada
Innovaderm Research Inc.
RECRUITING
Montreal
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2024-11-22
Estimated Completion Date: 2025-11-21
Participants
Target number of participants: 52
Treatments
Experimental: 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.
Experimental: 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.
Placebo_comparator: Placebo
All participants will receive Placebo QD. Area of application will be increased as the study proceeds from one cohort to the next.
Related Therapeutic Areas
Sponsors
Leads: Pfizer

This content was sourced from clinicaltrials.gov