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Phosphodiesterase-4 (PDE4) Inhibitor

Topical Roflumilast for Plaque Psoriasis (DERMIS-OLE Trial)

Phase 3
Waitlist Available
Research Sponsored by Arcutis Biotherapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights

DERMIS-OLE Trial Summary

This trial will study a new cream to treat plaque psoriasis. The cream will be applied once a day for 24 weeks.

Who is the study for?
This trial is for males and females aged 2 years and older with chronic plaque psoriasis. Participants must be able to consent or have a guardian's consent, not have serious health issues, avoid excessive sun exposure, and not abuse drugs or alcohol. Women of childbearing age must test negative for pregnancy and use contraception.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of ARQ-151 cream (topical roflumilast) applied daily for 24 weeks on individuals with chronic plaque psoriasis. It includes those who've completed a prior ARQ-151 study as well as treatment-naïve participants.See study design
What are the potential side effects?
While specific side effects are not listed here, potential risks may include reactions at the application site or other adverse events that could arise from long-term topical medication use.

DERMIS-OLE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 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
Occurrence of treatment emergent AEs (TEAEs)
Secondary outcome measures
Achievement of a 100% reduction in PASI over time
Achievement of a 50% reduction in (Psoriasis Area Severity Index) PASI over time
Achievement of a 75% reduction in PASI over time
+4 more

DERMIS-OLE Trial Design

1Treatment groups
Experimental Treatment
Group I: ARQ-151 Cream 0.3%Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Topical roflumilast
2020
Completed Phase 3
~340

Find a Location

Who is running the clinical trial?

Arcutis Biotherapeutics, Inc.Lead Sponsor
21 Previous Clinical Trials
7,308 Total Patients Enrolled
David Berk, MDStudy DirectorArcutis Biotherapeutics, Inc.
21 Previous Clinical Trials
8,302 Total Patients Enrolled

Media Library

Plaque Psoriasis Research Study Groups: ARQ-151 Cream 0.3%

Frequently Asked Questions

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

Are patients being actively sought for this experiment?

"This particular clinical trial, as recorded on the website clinicaltrials.gov, is not currently looking for patients to participate. This study was originally posted on February 12th 2020 and updated November 9th of 2022. There are, however, 189 other trials that are recruiting patients."

Answered by AI

Does the age limit for this test extend past 25 years old?

"According to the eligibility requirements listed on this clinical trial, patients must be aged 2-11. There are a total of 33 clinical trials for children under 18 and 160 for adults over 65 years old."

Answered by AI

What are the possible side effects of using Topical roflumilast?

"Topical roflumilast has undergone multiple rounds of testing and has been proven effective, making it a safe choice with a score of 3."

Answered by AI

How many people are being allowed to participate in this trial?

"Unfortunately, this trial is not looking for new patients at the moment. The listing was first created on February 12th 2020 and edited most recently on November 9th 2022. However, there are presently 179 other trials actively recruiting psoriasis patients and 10 topical roflumilast studies also admitting participants."

Answered by AI

How can I sign up for this opportunity to participate in this research?

"Eligibility for this psoriasis study requires that patients be aged 2-11. Up to 285 individuals will be enrolled in the clinical trial."

Answered by AI

How many different medical centers are conducting this experiment?

"83 clinical sites are running this study, including Arcutis Biotherapeutics Clinical Site 509 in Fountain Valley, Pennsylvania, Arcutis Biotherapeutics Clinical Site 511 in Rancho Santa Margarita, Texas, and Arcutis Biotherapeutics Clinical Site 113 in Exton, North carolina."

Answered by AI

Is roflumilast the first medication of its kind?

"Roflumilast was first trialed in 2018 at Mays Cancer Center, UT Health San Antonio. Since then, there have been 47 completed studies with roflumilast. Presently, 10 clinical trials are recruiting patients with several of these based in Fountain Valley, Pennsylvania."

Answered by AI

Who else is applying?

What state do they live in?
Kentucky
Other
North Carolina
Florida
How old are they?
18 - 65
What site did they apply to?
Arcutis Biotherapeutics Clinical Site 217
Arcutis Biotherapeutics Clinical Site 238
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
2
1

Why did patients apply to this trial?

I want my scalp psoriasis to go away. Used talconex in a blind study and worked for three years on scalp. Using intermittent steroids on body and tried ointment from Canada called longivity active ingredient coal tar. Live in central Florida. Interested in Sanford trial.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Open-Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis
2020. "Open-Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04286607.
~64 spots leftby Apr 2025
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