Roflumilast Cream for Psoriasis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a cream called roflumilast, which may help individuals with chronic plaque psoriasis and nail psoriasis. The goal is to assess the cream's effectiveness when applied daily to affected nails and skin patches. Individuals with stable psoriasis and nail issues for at least six months, and psoriasis on multiple body areas (excluding the scalp, palms, and soles), may be suitable candidates. Participants will use the cream for 24 weeks, aiming to find symptom relief. As a Phase 4 trial, this research seeks to understand how this already FDA-approved and effective treatment benefits more patients, offering an opportunity to contribute to broader knowledge while potentially finding relief.
What is the safety track record for this treatment?
Research has shown that roflumilast 0.3% cream is safe and effective for treating plaque psoriasis. Studies have confirmed its FDA approval for individuals aged 12 and older. Both adults and children with psoriasis have successfully used it.
Common side effects are mild and may include diarrhea, headache, and trouble sleeping, occurring in only a small number of people. Overall, the cream is considered safe, allowing most people to use it without serious problems. This makes it a promising option for those considering participation in the clinical trial.12345Why are researchers enthusiastic about this study treatment?
Roflumilast cream is unique because it offers a topical approach to treating psoriasis, which sets it apart from many existing treatments like systemic biologics and oral medications. Unlike most psoriasis treatments that target the immune system broadly, Roflumilast cream works by specifically inhibiting an enzyme called phosphodiesterase-4 (PDE4), which plays a key role in inflammation. This specific mechanism can help reduce inflammation and plaque buildup with potentially fewer side effects. Researchers are excited about this treatment because it combines targeted action with the convenience and safety of a topical application.
What is the effectiveness track record for Roflumilast Cream in treating psoriasis?
Research has shown that roflumilast 0.3% cream effectively treats chronic plaque psoriasis. In one study, 95% of participants using the cream noticed improvements by week 8. Another study found that 57.1% of patients achieved clear or almost clear skin during the trial. The treatment is well-tolerated, with over 97% of patients not experiencing irritation. This cream is already approved and quickly reduces plaques and itching.678910
Are You a Good Fit for This Trial?
This trial is for males and females aged 12 or older with chronic plaque psoriasis (including moderate to severe nail psoriasis) that has been stable for at least 6 months. Participants must be in good health, not pregnant or breastfeeding, and able to follow study instructions.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants apply roflumilast 0.3% cream daily for 24 weeks to affected nails and psoriasis plaques
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Roflumilast 0.3% Cream
Trial Overview
The study tests the effectiveness and safety of roflumilast 0.3% cream applied daily to affected nails for 24 weeks and to skin plaques until they clear. All participants receive the same treatment; there is no placebo group.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Modern Research Associates, PLLC
Lead Sponsor
Citations
Long-term Safety and Efficacy of Roflumilast Cream 0.3% ...
Long-term Safety and Efficacy of Roflumilast Cream 0.3% in Adult Patients With Chronic Plaque Psoriasis: Results From a 52-Week, Phase 2b Open-Label Study.
New Data Shows ZORYVE® (Roflumilast) Cream 0.3% ...
95% of individuals treated with ZORYVE had a measurable improvement in Psoriasis Area and Severity Index (PASI) at Week 8 Over 85% achieved ...
Roflumilast-treated patients sustain psoriasis clearance for ...
57.1% of patients treated with roflumilast 0.3% cream achieved an IGA score of clear or almost clear during any point in the study.
Roflumilast cream shows long-term efficacy, tolerability in ...
By the end of the study, more than 97% of patients experienced no irritation. Once-daily roflumilast cream 0.3% was well tolerated and ...
Roflumilast Cream 0.3% in Patients with Chronic Plaque ...
At week 8, statistically significantly more roflumilast- than vehicle-treated patients achieved ≥ 75% reduction in PASI (40.3% vs 6.5%; P < ...
Results & Side Effects | ZORYVE® (roflumilast) 0.3% cream
It is not known if ZORYVE foam is safe and effective in children with plaque psoriasis of the scalp and body under 12 years of age.
42828 Efficacy and safety of roflumilast cream 0.3% in ...
Roflumilast cream 0.3% provided superior improvement across multiple efficacy endpoints versus vehicle with favorable safety and tolerability in patients with ...
FDA Accepts Supplemental New Drug Application for ...
The most common adverse reactions reported (≥1%) for ZORYVE cream 0.3% for plaque psoriasis were diarrhea (3.1%), headache (2.4%), insomnia (1. ...
ZORYVE™ (roflumilast) cream, for topical use
The safety and effectiveness of ZORYVE have been established in pediatric patients ages 12 years and older for the treatment of plaque psoriasis.
NCT06648772 | Efficacy and Safety of Roflumilast Cream ...
Efficacy and Safety of Roflumilast Cream 0.3% in Subjects With Plaque Psoriasis: a Phase 3 Study ClinicalTrials.gov. For topical use, Q.D. Intervention/ ...
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