An Open Label Trial to Evaluate Efficacy and Safety of Roflumilast 0.3% Cream for Chronic Plaque … (NCT07725822) | Clinical Trial Compass
Not Yet RecruitingPhase 4
An Open Label Trial to Evaluate Efficacy and Safety of Roflumilast 0.3% Cream for Chronic Plaque and Nail Psoriasis
United States15 participantsStarted 2026-08
Plain-language summary
This is an open label trial in subjects ≥12 years of age and older with chronic plaque psoriasis and moderate to severe nail psoriasis.
Eligible participants will apply roflumilast 0.3% cream daily for 24 weeks to affected nails daily for the entire study duration and to psoriasis plaques daily until clear.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Participants legally competent to sign and give informed consent.
. Males and females ages 12 years of age and older.
. Clinical diagnosis of psoriasis vulgaris of at least 6 months duration as determined by the Investigator. Stable psoriasis for the past 6 months and stable nail disease for the past 6 months.
. Psoriasis vulgaris on the face, extremities, trunk, and/or intertriginous areas and groin (excluding the scalp, palms and soles).
. Nail psoriasis affecting ≥3 fingernails on hands.
. An Investigator's Global Assessment of disease severity (IGA) or (I-IGA) of at least Almost Clear ('1') at Baseline
. Females of childbearing potential (FOCBP) must have a negative urine pregnancy test at Screening (Visit 1) and a negative urine pregnancy test at Baseline (Visit 2) (if not combined).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean Change in Nail Psoriasis Severity Index (NAPSI)
. In good health as judged by the Investigator, based on medical history, physical examination.
Exclusion criteria
. Subjects who cannot discontinue medication and treatments prior to the Baseline visit and during the study according to Excluded Medications and Treatments (Table 1).
. Subjects who currently have or plan to have gel or acrylic overlays on nails during the study.
. Subjects who cannot discontinue nail care habits that will confound efficacy and safety assessments (e.g. buffing, filing, excessive trimming). Routine simple clipping is allowed.
. Subjects who cannot discontinue any nail topcoat products (e.g. hardeners, strengtheners, nail polish) Simple nail polish will be allowed for special events and removed the next day. Subject will note in diary days this occurs and the total days may not exceed 5 study days.
. Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED.
. Subjects currently taking lithium or antimalarial drugs.
. Planned initiation or changes to concomitant medication that could, in the opinion of the Investigator, affect psoriasis vulgaris (e.g. beta blockers, ACE inhibitors).