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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Plaque and Nail Plate Psoriasis
• Intervention / Treatment: Drug: Roflumilast 0.3% topical cream

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Stacy Reed; Phone Number: 214-361-2008; Email: stacy@mradallas.com
• Study Contact Backup: Name: Melodie Young, NP; Phone Number: 214-361-2008; Email: melodienp@mradallas.com

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75231
      • Modern Research Associates, PLLC
      • Contact: Stacy Reed; Phone Number: 214-361-2008; Email: stacy@mradallas.com
      • Principal Investigator: Melodie Young, MSN, A/GNP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

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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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Roflumilast 0.3% topical cream	Drug: Roflumilast 0.3% topical cream; Roflumilast 0.3% topical cream QD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in NAPSI	The Primary Efficacy Endpoint is NAPSI mean change from baseline at week 24	24 weeks

Collaborators and Investigators

• Sponsor: Modern Research Associates, PLLC

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: July 21, 2026
• First Submitted That Met QC Criteria: July 21, 2026
• First Posted (Actual): July 24, 2026

Study Record Updates

• Last Update Posted (Actual): July 24, 2026
• Last Update Submitted That Met QC Criteria: July 21, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Chronic Plaque Psoriasis and Nail Plate Psoriasis
• Additional Relevant MeSH Terms: Roflumilast
• Other Study ID Numbers: ARQ-MA-000276

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No