Chronic Plaque Psoriasis study: Roflumilast
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
What this study is testing
What is Roflumilast 0.3% topical cream?
An investigational topical cream being studied for chronic plaque psoriasis and moderate to severe nail psoriasis. It is designed to inhibit phosphodiesterase‑4, which may reduce inflammation in the skin and nails.
Also referred to as Roflumilast.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether roflumilast cream helps clear plaque and nail psoriasis.
- Who it's for
- You may be able to join if you are 12 or older and have moderate to severe plaque or nail psoriasis.
- What's involved
- You will apply the cream to your nails every day for 24 weeks and to skin plaques daily until they clear. You will have visits to check your progress.
- Time commitment
- The study lasts 24 weeks, with regular visits to monitor your skin and nails.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- 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.
- 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.
You likely can't join if
- people who cannot discontinue medication and treatments prior to the Baseline visit and during the study according to Excluded Medications and...
- people who currently have or plan to have gel or acrylic overlays on nails during the study.
- people who cannot discontinue nail care habits that will confound how well it works and safety assessments (e.g.
- people who cannot discontinue any nail topcoat products (e.g. hardeners, strengtheners, nail polish) Simple nail polish will be allowed for special...
- Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED.
- people currently taking lithium or antimalarial drugs.
See the full eligibility 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).
- 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.
- people who cannot discontinue medication and treatments prior to the Baseline visit and during the study according to Excluded Medications and Treatments (Table 1).
- people who currently have or plan to have gel or acrylic overlays on nails during the study.
- people who cannot discontinue nail care habits that will confound how well it works and safety assessments (e.g. buffing, filing, excessive trimming). Routine simple clipping is allowed.
- people 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.
- Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED.
- people 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).
- Current diagnosis of drug-induced psoriasis.
- Any recent infection, presence of onychomycosis or any other confounding nail disorder as determined by investigator.
- people with any condition on the treatment area which, in the opinion of the Investigator, could confound how well it works measurements.
- Known allergies to excipients in roflumilast cream (petrolatum, isopropyl palmitate, methylparaben, propylparaben, diethylene glycol monoethyl ether, hexylene glycol, cetylstearyl alcohol, dicetyl phosphate and...
- Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
- Previous treatment with any topical PDE4i. people who have received oral roflumilast (Daliresp®, Daxas®) or other PDE4 inhibitors (apremilast) within the past 6 months.
- 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
- people with a history of chronic alcohol or drug abuse within 6 months of initiation of study medication.
- people with a history of a major surgery within 4 weeks prior to Baseline (Visit 2) or has a major surgery planned during the study.
- people 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.
- people who are family members of the clinical study site, clinical study staff / sponsor, or family members of enrolled people.
- people 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Dallas, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.