An Open Label Trial to Evaluate Efficacy and Safety of Roflumilast 0.3% Cream for Chronic Plaque and Nail Psoriasis
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- No age limits stated
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 24 weeks
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests how well roflumilast 0.3% cream works and how safe it is for people ages 12 and older with long-term plaque psoriasis and moderate to severe nail psoriasis. Participants apply the cream daily to affected nails for 24 weeks and to raised skin patches until they clear.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Age 12 or older and legally able to sign the consent form.
- Have plaque psoriasis diagnosed by the study doctor for at least 6 months. Skin and nail psoriasis must have been stable for the past 6 months.
- Have psoriasis on the face, arms, legs, trunk, skin folds, or groin. The scalp, palms, and soles do not count.
- Have nail psoriasis in at least 3 fingernails.
- Have a doctor's skin disease rating of at least 1, meaning “almost clear,” at the starting visit.
- If able to become pregnant, have negative urine pregnancy tests at screening and the starting visit, unless these visits are combined.
- If able to become pregnant and sexually active, use highly effective birth control during the study. Barrier methods require two forms. Not having sex is allowed if it is your usual choice and you have a backup birth control plan.
- Be in good health based on the study doctor's review and exam.
Who can't join
- Cannot stop medicines or treatments banned by the study; take lithium or malaria drugs; or plan medicine changes that could affect psoriasis. Also excluded: psoriasis caused by medicine, any past use of a PDE4-blocking skin treatment, or use of oral roflumilast or another PDE4 blocker within 6 months.
- Have or plan gel or acrylic nails, or cannot stop buffing, filing, excessive trimming, or nail coatings. Simple clipping is allowed. Plain polish is allowed for special events only, must be removed the next day and recorded, and may be used for no more than 5 study days.
- Plan too much sunlight, tanning bed use, or other LED light exposure on treated areas; have a recent infection, nail fungus, or another nail or skin problem that could affect study results.
- Are pregnant, breastfeeding, or planning pregnancy during the study; or have an allergy to study drug ingredients or a history of a serious allergic reaction to PDE4 blockers.
- Have known or suspected severe kidney disease, moderate to severe liver disease, HIV, a history of severe depression or suicidal thoughts, or another serious health problem or abnormal lab result that makes participation unsafe. Alcohol or drug abuse within the past 6 months also excludes you.
- Had major surgery within 4 weeks before the starting visit or plan major surgery during the study. Cancer now or within the past 5 years also excludes you, except fully treated basal cell or squamous cell skin cancer, or early cervical cancer that has not spread.
- Cannot communicate, read, or understand the local language, or have another condition the study doctor believes makes participation unsuitable.
- Are study staff or sponsor personnel, a family member of study site staff or sponsor personnel, or a family member of an enrolled participant.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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.
Study sites (1)
TX
- Modern Research Associates, PLLC · Dallas, TX 75231Stacy Reed · Study contact · 214-361-2008 · stacy@mradallas.comMelodie Young, MSN, A/GNP · Principal investigatorMore trials in Dallas