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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
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I am willing to use birth control to prevent pregnancy or fathering a child.
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My skin condition is severe with significant facial involvement.
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I am 18 years or older and have signed the consent form.
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I am of childbearing age and have a negative pregnancy test.
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I agree to stop all other treatments for my skin condition during the study, except for the study drug.

Timeline

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

Find a Location

Who is running the clinical trial?

PfizerIndustry Sponsor
4,567 Previous Clinical Trials
10,908,238 Total Patients Enrolled
Icahn School of Medicine at Mount SinaiLead Sponsor
858 Previous Clinical Trials
524,225 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

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

~29 spots leftby Dec 2024