PF-07905428 for Acne

Not currently recruiting at 2 trial locations

Overseen By Pfizer CT.gov Call Center

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Pfizer

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

Compensation: Varies

Number of Visits: 18

Duration: 2-4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new acne treatment called PF-07905428, a topical medication, to determine its safety and effectiveness for people with acne vulgaris. Participants apply the treatment daily on the face and/or back. The study compares the experiences of those using the treatment with those using a placebo, which contains no active medicine. It seeks generally healthy individuals diagnosed with moderate to severe acne. Participants will visit the clinic up to 31 times over about two months. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that PF-07905428 remains in the early stages of testing, so detailed safety information is limited. Phase 1 trials primarily assess the safety of a new treatment. In this phase, researchers observe how well participants tolerate the treatment and monitor for any side effects.

For PF-07905428, the study examines how individuals react to varying doses when applied to the skin. This process helps determine safety and potential side effects. As a Phase 1 trial, the treatment has not yet been proven safe in a large group. However, researchers will closely monitor participants to ensure their safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for acne?

Researchers are excited about PF-07905428 for acne because it introduces a novel approach to treatment with its unique active ingredient. Unlike standard treatments like benzoyl peroxide or salicylic acid, PF-07905428 is available in both high (0.24%) and low (0.08%) strengths, allowing for tailored application that can be adjusted throughout treatment. This flexibility may provide enhanced control over acne severity and minimize side effects. Additionally, the study's design to gradually increase the application area could lead to more comprehensive and potentially faster results compared to traditional spot treatments.

What evidence suggests that PF-07905428 might be an effective treatment for acne?

Research has shown that PF-07905428 affects the processes that cause acne. Early lab studies indicate it can reduce inflammation and bacteria, which are key causes of acne. Initial results suggest this treatment might help clear up skin by reducing pimples and redness. Although limited data from human studies exist, the mechanism of PF-07905428 offers hope for its effectiveness in treating acne. This trial will study different strengths of PF-07905428, including high and low strengths, as well as a placebo. As a new treatment under study, ongoing research will provide clearer evidence of its benefits.

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

Participants with clinically significant laboratory abnormalities

Participants with autoinflammatory syndromes

I have a significant history of major health issues.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• PF-07905428

Trial Overview 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.

How Is the Trial Designed?

Group I: PF-07905428 Low Strength Experimental Treatment 1 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 Strength Experimental Treatment 1 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: Placebo Placebo Group 1 Intervention

All participants will receive Placebo QD. Area of application will be increased as the study proceeds from one cohort to the next.

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Citations

1. cdn.pfizer.com cdn.pfizer.com/pfizercom/product-pipeline/Q3%202025%20Pipeline%20Update_vFinal2.pdf?VersionId=P0rxbPkdVnYPsxzIj_uO3wzb.sXa287Z

Pfizer Pipeline Treatment with TUKYSA in combination with trastuzumab and pertuzumab was tolerable, with a safety profile generally consistent with the ...

2. trial.medpath.com trial.medpath.com/drug/report/7f3f5344003a245c

PF-07905428 | Advanced Drug Monograph - MedPath PF-07905428 is an investigational drug candidate under development by Pfizer Inc. for the topical treatment of acne vulgaris. Currently in Phase ...

3. pfizerclinicaltrials.com pfizerclinicaltrials.com/find-a-trial/nct06671834-acne-vulgaris-trial

Clinical Trial for Acne Vulgaris. 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 ...

4. withpower.com withpower.com/trial/phase-1-acne-vulgaris-10-2024-5662c

PF-07905428 for Acne · Recruiting Participants for Phase ... This Phase 1 medical study run by Pfizer is evaluating whether PF-07905428 will have tolerable side effects & efficacy for patients with Acne and Acne.

5. synapse.patsnap.com synapse.patsnap.com/drug/88b17645eed34c829d637c8ea14b0362

PF-07905428 - Drug Targets, Indications, Patents A Phase 1, Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety, Tolerability, ...