An Open Label Trial to Evaluate Efficacy and Safety of Roflumilast 0.3% Cream for Chronic Plaque and Nail Psoriasis

NCT07725822 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: ARQ-MA-000276
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Plaque Psoriasis; Nail Psoriasis

Keywords

Chronic Plaque Psoriasis; Nail Psoriasis

Outcome Measures

Primary Outcomes (1)

• Mean Change in Nail Psoriasis Severity Index (NAPSI)

  The Primary Efficacy Endpoint is NAPSI mean change from baseline at week 24

  24 weeks

Study Arms (1)

Roflumilast 0.3% topical cream

EXPERIMENTAL

Drug: Roflumilast 0.3% topical cream

Interventions

Roflumilast 0.3% topical cream DRUG

Roflumilast 0.3% topical cream QD

Roflumilast 0.3% topical cream

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify 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. 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.

You may not qualify if:

• Subjects who cannot discontinue medication and treatments prior to the Baseline visit and during the study according to Excluded Medications and Treatments (Table 1).
• 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 will confound efficacy and safety assessments (e.g. buffing, filing, excessive trimming). Routine simple clipping is allowed.
• 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.
• Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED.
• Subjects 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.
• Subjects with any condition on the treatment area which, in the opinion of the Investigator, could confound efficacy measurements.
• 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).
• Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
• Previous treatment with any topical PDE4i. Subjects who have received oral roflumilast (Daliresp®, Daxas®) or other PDE4 inhibitors (apremilast) within the past 6 months.
• Known or suspected:
• severe renal insufficiency or moderate to severe liver impairment (Child-Pugh B or C)

Sponsors & Collaborators

• Modern Research Associates, PLLC: lead

Study Sites (1)

Modern Research Associates, PLLC

Dallas, Texas, 75231, United States

Location

MeSH Terms

Interventions

Roflumilast

Central Study Contacts

Stacy Reed

CONTACT

214-361-2008; stacy@mradallas.com

Melodie Young, NP

CONTACT

214-361-2008; melodienp@mradallas.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 24, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)