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Phosphodiesterase-4 (PDE4) Inhibitor
Roflumilast Cream for Eczema (INTEGUMENT-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
Females of childbearing potential (FOCBP) must have a negative urine pregnancy test at all study visits. In addition, sexually active FOCBP must agree to use at least one form of a highly effective or barrier method of contraception throughout the trial.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 or 52 weeks
Awards & highlights
INTEGUMENT-OLE Trial Summary
This trial will study how safe and effective a cream is for people with eczema when used once a day for a year.
Who is the study for?
This trial is for individuals who have atopic dermatitis (eczema) and completed a previous related study. It's open to males and females aged 2 years and up, but only adults in Québec, Canada. Participants must be reliable in following the study plan. Women of childbearing age need a negative pregnancy test and must use effective contraception.Check my eligibility
What is being tested?
The trial tests ARQ-151 cream (0.15% or 0.05%) applied daily for one year to see how safe it is and how well it works for managing eczema symptoms.See study design
What are the potential side effects?
Potential side effects are not detailed here, but as with any topical cream, there could be risks of skin irritation, redness, itching or allergic reactions.
INTEGUMENT-OLE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am able to have children, will test for pregnancy, and agree to use birth control during the trial.
INTEGUMENT-OLE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 or 52 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 or 52 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To assess long-term safety in a multicenter, open-label, single-arm, 52-week study in subjects with atopic dermatitis treated with ARQ-151 cream: AEs and SAEs
Secondary outcome measures
EASI score over time
Validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) score of 0 or 1 at each assessment
WI-NRS score over time
+1 moreINTEGUMENT-OLE Trial Design
1Treatment groups
Experimental Treatment
Group I: ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05%Experimental Treatment1 Intervention
ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05%
Find a Location
Who is running the clinical trial?
Arcutis Biotherapeutics, Inc.Lead Sponsor
21 Previous Clinical Trials
6,421 Total Patients Enrolled
David Berk, MDStudy DirectorArcutis Biotherapeutics, Inc.
21 Previous Clinical Trials
7,415 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have atopic dermatitis and completed a previous study for at least four weeks, and you are able to join this long-term safety study at the four-week mark of the previous study.I am not currently using any medications that are not allowed in the study.I do not have skin conditions that could affect study results, as confirmed by a doctor.I am legally able to consent, or for minors, consent is given by a parent/guardian.I am able to have children, will test for pregnancy, and agree to use birth control during the trial.I had a serious side effect from ARQ-151 cream that stopped me from continuing its use.I am 2 years or older, or 18 and older if I'm in Québec, Canada.I am a woman who cannot become pregnant due to age, surgery, or other reasons.I have a genetic skin condition that is similar to atopic dermatitis.I (or my child) can follow the study plan and attend all appointments.I am not pregnant, trying to get pregnant, or breastfeeding.
Research Study Groups:
This trial has the following groups:- Group 1: ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05%
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Atopic Dermatitis Patient Testimony for trial: Trial Name: NCT04804605 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any dangers in using ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05%?
"ARQ-151 Cream 0.15% and ARQ-151 Cream 0.05% have both undergone Phase 3 clinical trials, so there is a significant amount of data supporting both its efficacy and safety."
Answered by AI
How large is the target population for this clinical trial?
"In order to successfully complete this clinical trial, 1500 eligible patients must participate. The trial locations include Arcutis Clinical Site 61 in Peterborough, Ontario and Arcutis Clinical Site 41 in Charleston, South carolina."
Answered by AI
Where are patients being treated in this clinical trial?
"For this research project, there are 92 patients enrolled from locations including Arcutis Clinical Site 61 in Peterborough, Arcutis Clinical Site 41 in Charleston, and other global sites."
Answered by AI
Are patients able to sign up for this experiment at this time?
"Yes, as of 8/4/2022, this study is still looking for 1500 more participants. It was posted on 2/25/2021 and was last updated recently. 92 sites are recruiting patients for the trial."
Answered by AI
Who else is applying?
What state do they live in?
California
Ontario
Texas
How old are they?
18 - 65
What site did they apply to?
Arcutis Clinical Site 69
Arcutis Clinical Site 24
Arcutis Clinical Site 130
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1
3+
Why did patients apply to this trial?
I have been having AD for more than 20 years and dermovate is not working for me , Also I have dry skin and dandruff.
PatientReceived 2+ prior treatments
I have went to several doctors pertaining to my issue thinking it was one condition versus another condition, and all topical medications didn’t work with me. I wanted something that truly worked.
PatientReceived 2+ prior treatments
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