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Roflumilast Cream for Psoriasis

SR
MY
Overseen ByMelodie Young, NP
Age: Any Age
Sex: Any
Trial Phase: Phase 4
Sponsor: Modern Research Associates, PLLC
Must not be taking: Lithium, Antimalarials, PDE4 inhibitors
Disqualifiers: Onychomycosis, Severe depression, Cancer, others
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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

I am not pregnant and will use effective birth control during the trial.
Investigator's Global Assessment of disease severity (IGA) or (I-IGA) of at least Almost Clear ('1') at Baseline
In good health as judged by the Investigator based on medical history and physical examination
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Exclusion Criteria

Subjects who cannot discontinue medication and treatments prior to Baseline visit and during the study according to Excluded Medications and Treatments
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 confound efficacy and safety assessments (e.g. buffing, filing, excessive trimming)
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants apply roflumilast 0.3% cream daily for 24 weeks to affected nails and psoriasis plaques

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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

Group I: Roflumilast 0.3% topical creamExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Modern Research Associates, PLLC

Lead Sponsor

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