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Roflumilast 0.3% Cream for Chronic Plaque and Nail Psoriasis

This study is testing a cream called roflumilast 0.3% to see how well and safely it treats chronic plaque psoriasis and moderate to severe nail psoriasis. You might be able to join if you are 12 years or older and have had psoriasis for at least 6 months. Participants will apply the cream daily to affected nails for 24 weeks and to skin plaques until they clear. The main goal is to see how much the severity of nail psoriasis changes after 24 weeks. The current status of this study is unclear, and it plans to enroll 15 people.

Study design
This is an open-label study, meaning both you and the study team will know you are receiving roflumilast 0.3% cream. It plans to include 15 participants.
What's involved
You would apply roflumilast 0.3% cream daily to your affected nails for 24 weeks and to your psoriasis plaques daily until they clear.
Compensation
Not stated in the trial record.
Follow-up
The main measurement for the study is taken at 24 weeks.

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NCT07725822

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

Not Yet Recruiting
PHASE4All AgesInterventionalTreatment
Modern Research Associates, PLLC
~15 participants
Updated 2026-07-28 on ClinicalTrials.gov
What's tested:Roflumilast 0.3% topical cream

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mean Change in Nail Psoriasis Severity Index (NAPSI)
Measured over 24 weeks

Conditions

Chronic Plaque Psoriasis
Nail Psoriasis

Explore related trials

Chronic small plaque psoriasisPsoriasis of nail

Where it's being run

1 sites across 1 states
Texas1

Who to contact

Stacy Reed
[email protected]
214-361-2008
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

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.

What this trial measures

  • Mean Change in Nail Psoriasis Severity Index (NAPSI)24 weeks

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