Topical roflumilast for Plaque Psoriasis

Phase-Based Progress Estimates
Arcutis Clinical Site 602, Boise, IDPlaque PsoriasisTopical roflumilast - Drug
2 - 11
All Sexes
What conditions do you have?

Study Summary

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

Eligible Conditions
  • Chronic Plaque Psoriasis

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: 24 weeks

24 weeks
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
Achievement of a 90% reduction in PASI over time
Achievement of an Investigator Global Assessment (IGA) of 'clear' or 'almost clear' over time.
Change in Worst Itch Numeric Rating Scale) WI-NRS score over time
In subjects who achieve a 'clear' IGA time to re-starting investigational product (duration of response).
Occurrence of treatment emergent AEs (TEAEs)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

1 Treatment Group

ARQ-151 Cream 0.3%
1 of 1

Experimental Treatment

285 Total Participants · 1 Treatment Group

Primary Treatment: Topical roflumilast · No Placebo Group · Phase 3

ARQ-151 Cream 0.3%
Experimental Group · 1 Intervention: Topical roflumilast · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 24 weeks

Who is running the clinical trial?

Arcutis Biotherapeutics, Inc.Lead Sponsor
21 Previous Clinical Trials
7,547 Total Patients Enrolled
David Berk, MDStudy DirectorArcutis Biotherapeutics, Inc.
21 Previous Clinical Trials
8,541 Total Patients Enrolled

Eligibility Criteria

Age 2 - 11 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Who else is applying?

What state do they live in?
How old are they?
18 - 65100.0%
What site did they apply to?
Arcutis Biotherapeutics Clinical Site 21750.0%
Arcutis Biotherapeutics Clinical Site 23850.0%
What portion of applicants met pre-screening criteria?
Met criteria50.0%
Did not meet criteria50.0%
How many prior treatments have patients received?

Frequently Asked Questions

Are patients being actively sought for this experiment?

"This particular clinical trial, as recorded on the website, 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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.