Chronic Plaque PsoriasisPhase 4NCT07725822
An Open Label Trial to Evaluate Efficacy and Safety of Roflumilast 0.3% Cream for Chronic Plaque and Nail Psoriasis
A Phase 4 study testing Roflumilast 0.3% topical cream in people with Chronic Plaque Psoriasis and Nail Psoriasis, run by Modern Research Associates, PLLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Plaque Psoriasis, Nail Psoriasis
- What is being tested?
- Roflumilast 0.3% topical cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2026to Aug 2027
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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).
- In addition, sexually active FOCBP must agree to use at least one form of highly effective contraception throughout the trial.
- Highly effective forms of contraception include: oral/implant/injectable/transdermal contraceptives, intrauterine device, and partner's vasectomy.
- If barrier methods are used (e.g., condom with spermicide, diaphragm with spermicide), then 2 forms of conception are required.
- The use of abstinence as a contraceptive measure is acceptable as long as this is a consistent part of a lifestyle choice and an acceptable backup method has been identified if the subject becomes sexually active.
- In good health as judged by the Investigator, based on medical history, physical examination.
Who cannot join
- 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.
Show all 25Show fewer
- Planned initiation or changes to concomitant medication that could, in the opinion of the Investigator, affect psoriasis vulgaris (e.g. beta blockers, ACE inhibitors).
- Current diagnosis of drug-induced psoriasis.
- Any recent infection, presence of onychomycosis or any other confounding nail disorder as determined by investigator.
- Subjects with any condition on the treatment area which, in the opinion of the Investigator, could confound efficacy measurements.
- Known allergies to excipients in roflumilast cream (petrolatum, isopropyl palmitate, methylparaben, propylparaben, diethylene glycol monoethyl ether, hexylene glycol, cetylstearyl alcohol, dicetyl phosphate and ceteth-10 phosphate).
- Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
- Previous treatment with any topical PDE4i. Subjects who have received oral roflumilast (Daliresp®, Daxas®) or other PDE4 inhibitors (apremilast) within the past 6 months.
- Known or suspected:
- severe renal insufficiency or moderate to severe liver impairment (Child-Pugh B or C)
- known HIV infection
- hypersensitivity to component(s) of the study drugs
- history of severe depression, suicidal ideation
- Subjects with a history of chronic alcohol or drug abuse within 6 months of initiation of study medication.
- Subjects with a history of a major surgery within 4 weeks prior to Baseline (Visit 2) or has a major surgery planned during the study.
- Subjects who are unable to communicate, read or understand the local language, or who display another condition, which in the Investigator's opinion, makes them unsuitable for clinical study participation.
- Subjects who are family members of the clinical study site, clinical study staff / sponsor, or family members of enrolled subjects.
- Subjects with any serious medical condition or laboratory abnormality that would prevent study participation or place the subject at significant risk, as determined by the Investigator.
- History of and/or concurrent condition of serious hypersensitivity (anaphylactic shock or anaphylactoid reaction) to PDE-4 inhibitors.
- Current or a history of cancer within 5 years with the exception of fully treated skin basal cell carcinoma, cutaneous squamous cell carcinoma or carcinoma in situ of the cervix.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Modern Research Associates, PLLC
Dallas, Texas, 75231
Stacy Reed, 214-361-2008, stacy@mradallas.com
Melodie Young, MSN, A/GNP
About this study
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.
- Conditions
- Chronic Plaque Psoriasis, Nail Psoriasis
- Being tested
- Roflumilast 0.3% topical cream
- Keywords
- Chronic Plaque Psoriasis, Nail Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roflumilast 0.3% topical creamDrug
Roflumilast 0.3% topical cream QD
| Study group | Role | What they receive |
|---|---|---|
| Roflumilast 0.3% topical cream | Experimental | Not described Receives: Drug: Roflumilast 0.3% topical cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Nail Psoriasis Severity Index (NAPSI)
The Primary Efficacy Endpoint is NAPSI mean change from baseline at week 24
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start15 Sep 2026
- Primary completionJul 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Plaque PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Modern Research Associates, PLLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07725822
- Sponsor's protocol ID
- ARQ-MA-000276
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No