Exploring the effects of PF-07905428 on acne vulgaris in healthy individuals and patients
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
This study is testing a new acne medication called PF-07905428 to see if it helps clear up acne in healthy people and patients aged 18 to 40.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | Pfizer Industry-sponsored |
| Locations | 1 site (Montréal, Quebec) |
| Trial ID | NCT06671834 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and efficacy of a new medication called PF-07905428 in treating acne vulgaris. Participants, aged 18 to 40, will be divided into cohorts based on their acne severity and will apply the study medication daily for either 14 or 28 days. The study will compare the outcomes of those receiving the medication to those receiving a placebo, with a total participation period of approximately two months and multiple study visits. The goal is to gather data on the medication's effects and safety profile.
Who should consider this trial
Good fit: Ideal candidates include healthy males and females aged 18 to 40, particularly those diagnosed with moderate to severe acne vulgaris.
Not a fit: Patients with very severe acne or those with significant underlying health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for individuals suffering from acne vulgaris.
How similar studies have performed: Other studies have shown promise in developing new treatments for acne vulgaris, but the specific approach of PF-07905428 is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Participants with very severe acne * Participants with autoinflammatory syndromes * Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease * History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C. * Participants with clinically significant laboratory abnormalities
Where this trial is running
Montréal, Quebec
- Innovaderm Research Inc. — Montréal, Quebec, Canada (Recruiting)
Study contacts
- Study coordinator: Pfizer CT.gov Call Center
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
- Phone: 1-800-718-1021
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.