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
- Are there results?
- Not yet: the study is under way
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
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- 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.
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- 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
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Trial to Evaluate Efficacy and Safety of Roflumilast 0.3% Cream for Chronic Plaque and Nail Psoriasis
- ClinicalTrials.gov ID
- NCT07725822
- Acronym / sponsor ID
- ARQ-MA-000276
- Conditions
- Chronic Plaque Psoriasis, Nail Psoriasis
- Keywords
- Chronic Plaque Psoriasis, Nail Psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Modern Research Associates, PLLCUniversity, hospital or other
- Study start
- 15 Sep 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 24 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Roflumilast 0.3% topical cream | Experimental | Drug: Roflumilast 0.3% topical cream |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (25 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Roflumilast 0.3% topical creamRoflumilast 0.3% topical cream QD | Drug | Roflumilast 0.3% topical cream |
Primary outcome
Mean Change in Nail Psoriasis Severity Index (NAPSI)
Time frame: 24 weeks
The Primary Efficacy Endpoint is NAPSI mean change from baseline at week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stacy Reed (214-361-2008, stacy@mradallas.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in Nail Psoriasis Severity Index (NAPSI) (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.