← Back to Search

PDE4 Inhibitor

PDE4 Inhibitor for Skin Conditions

Phase 2

Recruiting

Led By Benjamin Ungar, MD

Research Sponsored by Icahn School of Medicine at Mount Sinai

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male and female participants must be willing to take appropriate contraceptive measures to avoid pregnancy or fathering a child

Diagnosis of SD and baseline IGA ≥ 3 with facial involvement OR Diagnosis of PPR, baseline IGA ≥ 3, and baseline inflammatory lesion count ≥ 12

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 8 weeks, 12 weeks

Awards & highlights

Study Summary

This trial will test a new ointment to treat skin conditions Seborrheic Dermatitis and Papulopustular Rosacea in adults. Subjects will apply ointment once daily for 8 weeks and be monitored for improvement.

Who is the study for?

Adults over 18 with moderate-to-severe Seborrheic Dermatitis (SD) or Papulopustular Rosacea (PPR), who have specific severity scores and agree to avoid other treatments during the study. Participants must use effective contraception, be in good health, and not have used certain medications recently.Check my eligibility

What is being tested?

The trial is testing PF-07038124 ointment against a placebo for SD and PPR. It's double-blind, meaning neither participants nor researchers know who gets the real treatment. Subjects apply it daily for 8 weeks with follow-ups at weeks 4, 8, and 12.See study design

What are the potential side effects?

While specific side effects of PF-07038124 are not listed here, common side effects of topical treatments may include skin irritation, redness, itching or burning sensation at the application site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am willing to use birth control to prevent pregnancy or fathering a child.

Select...

My skin condition is severe with significant facial involvement.

Select...

I am 18 years or older and have signed the consent form.

Select...

I agree to stop all other treatments for my skin condition during the study, except for the study drug.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 8 weeks, 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 8 weeks, 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 8 weeks, 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Subjects reaching Investigator's Global Assessment (IGA) success - Seborrheic dermatitis (SD)

Percent change in lesion count Papulopustular Rosacea (PPR)

Secondary outcome measures

Change in Clinical Erythema - PPR

Change in IGA Score - SD and PPR

Change in Lesion count - PPR

+8 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: PF-07038124Experimental Treatment1 Intervention

PF-07038124 0.02% ointment once daily for 8 weeks

Group II: PlaceboPlacebo Group1 Intervention

Placebo Ointment

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

PfizerIndustry Sponsor

4,570 Previous Clinical Trials

10,915,940 Total Patients Enrolled

Icahn School of Medicine at Mount SinaiLead Sponsor

862 Previous Clinical Trials

525,560 Total Patients Enrolled

1 Trials studying Seborrheic Dermatitis

45 Patients Enrolled for Seborrheic Dermatitis

Benjamin Ungar, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai

1 Previous Clinical Trials

45 Total Patients Enrolled

1 Trials studying Seborrheic Dermatitis

45 Patients Enrolled for Seborrheic Dermatitis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential hazards are associated with PF-07038124?

"PF-07038124 is ranked a 2 for safety by our team at Power, as the existing clinical data confirms its security but there are still no studies examining efficacy."

Answered by AI

Are there vacancies available for prospective participants in this experiment?

"This research undertaking is actively recruiting participants and has been listed on clinicaltrials.gov since June 30th, 2023 with its most recent update occuring on August 22nd of the same year."

Answered by AI

How many volunteers are taking part in this research initiative?

"Yes, the information supplied by clinicaltrials.gov shows that this study is currently recruiting volunteers. It was posted on June 30th 2023 and updated most recently on August 22nd 2023. To date, only 66 participants have been enrolled across 1 site."

Answered by AI

What are the major aims of this research endeavor?

"The primary outcome of this study, evaluated over a baseline and 8-week timeframe, is the percentage change in lesion count for Papulopustular Rosacea (PPR). Secondary outcomes include: number of patients with treatment success based on Investigator's Global Assessment (IGA) - where clear(0) or almost clear (1) scores are considered successful; alteration from baseline in clinical erythema assessment; and variation from origin point as per patient severity rating of erythema. Each metric has an associated 0 to 4 scale that evaluates symptom intensity."

Answered by AI