Can a single cream tackle both skin and nail psoriasis?
NCT ID NCT07725822
First seen Jul 24, 2026 · Last updated Jul 29, 2026 · Updated 2 times
Summary
This trial tests whether a daily application of roflumilast 0.3% cream can improve both chronic plaque psoriasis and moderate-to-severe nail psoriasis. People aged 12 and older with stable disease for at least 6 months apply the cream to affected nails and plaques daily for 24 weeks. The main goal is to measure changes in nail psoriasis severity from the start to week 24.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- roflumilast 0.3% topical cream
- What this could lead to
- If effective, this cream could offer a new daily treatment option for both skin plaques and nail psoriasis with a single application.
- What could go wrong
- This is a small, open-label trial with only 15 participants, so results may not apply broadly. Side effects from topical roflumilast are possible, including skin irritation.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Participants legally competent to sign and give informed consent. 2. Males and females ages 12 years of age and older. 3. 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. 4. Psoriasis vulgaris on the face, extremities, trunk, and/or intertriginous areas and groin (excluding the scalp, palms and soles). 5. Nail psoriasis affecting ≥3 fingernails on hands. 6. An Investigator's Global Assessment of disease severity (IGA) or (I-IGA) of at least Almost Clear ('1') at Baseline 7. 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. 8. In good health as judged by the Investigator, based on medical history, physical examination. Exclusion Criteria: 1. Subjects who cannot discontinue medication and treatments prior to the Baseline visit and during the study according to Excluded Medications and Treatments (Table 1). 2. Subjects who currently have or plan to have gel or acrylic overlays on nails during the study. 3. 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. 4. 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. 5. Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED. 6. Subjects currently taking lithium or antimalarial drugs. 7. Planned initiation or changes to concomitant medication that could, in the opinion of the Investigator, affect psoriasis vulgaris (e.g. beta blockers, ACE inhibitors). 8. Current diagnosis of drug-induced psoriasis. 9. Any recent infection, presence of onychomycosis or any other confounding nail disorder as determined by investigator. 10. Subjects with any condition on the treatment area which, in the opinion of the Investigator, could confound efficacy measurements. 11. 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). 12. Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding. 13. Previous treatment with any topical PDE4i. Subjects who have received oral roflumilast (Daliresp®, Daxas®) or other PDE4 inhibitors (apremilast) within the past 6 months. 14. 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 15. Subjects with a history of chronic alcohol or drug abuse within 6 months of initiation of study medication. 16. 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. 17. 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. 18. Subjects who are family members of the clinical study site, clinical study staff / sponsor, or family members of enrolled subjects. 19. 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. 20. History of and/or concurrent condition of serious hypersensitivity (anaphylactic shock or anaphylactoid reaction) to PDE-4 inhibitors. 21. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Modern Research Associates, PLLC
Dallas, Texas, 75231, United States
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Other studies related to the condition(s) this trial covers.
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- Psoriasis Drug's skin gene secrets revealed in small trial
- Psoriasis drug showdown: which pill works better?
- Can a urea cream beat vaseline for nail psoriasis?
- New hope for nail psoriasis: tildrakizumab shows promise in trial
- New drug bimekizumab shows promise for psoriasis in early trial