What the trial was testing
The DERMIS enrolled 442 patients with psoriasis. The study was sponsored by Arcutis Biotherapeutics, Inc. and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was a large trial designed to confirm whether the treatment works well enough for wider use. Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.
What the results showed
40% of patients achieved clear or almost clear skin with roflumilast cream versus 6% with plain cream.
JAMA · 2022 · NCT04211389
These findings — that roflumilast cream cleared skin in 40% of patients versus 6% with plain cream — were published in the JAMA and represent the headline result of the study.
Researchers tracked outcomes across 442 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.
What this means for patients
For patients with psoriasis, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.
What you can do now
Roflumilast cream is now FDA-approved for plaque psoriasis. It's applied once daily and showed strong results in clearing skin and reducing itching. Talk to your dermatologist about whether this treatment is right for you.
Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.
Open psoriasis trials
Assessment of the Effect of a Dermatology-Oriented Spa Therapy on the Quality of Life of Patients With Psoriasis
Evaluation of the effect of a dermatology-oriented spa therapy at 4.5 months on the quality of life of patients suffering from psoriasis
HIPPOCRATES Prospective Observational Study
HIPPOCRATES is an Innovative Medicines Initiative (IMI) funded EU Consortium established to address key unmet clinical needs in psoriatic disease. As part of the project, the HIPPOCRATES Prospective Observational Study (HPOS) is a study of patients with psoriasis which will run across Europe. The study will be led by a research team at University of Oxford and supported by a team at University College Dublin. We are aiming to identify people with psoriasis who are at risk of developing psoriatic arthritis. Up to one-third of patients with psoriasis will develop a related arthritis causing inflammation in the joints and tendons. We want to identify which patients will develop arthritis with the long-term and ambitious aim of trying to prevent the development of arthritis before it occurs. We are recruiting/approaching adults with psoriasis and asking study participants to complete questionnaires every 6 months via a dedicated study website. The questionnaires will include a 'screening questionnaire' to try to identify arthritis. If participants are identified by the 'screening questionnaire' as having possible arthritis, they will be advised to seek local medical help. We will follow up with them to see if they are diagnosed with psoriatic arthritis. Alongside the questionnaire information from participants, we will ask some participants to provide a blood fingerprick sample using an easy to use at home sampling kit. The blood sample will be posted to a central location (University College Dublin) where it will be stored and then studied in the laboratory to look for markers that may predict the onset of arthritis. As many (most) participants will not develop arthritis, we are also studying the impact of psoriasis on the participants to learn more about how psoriasis affects people's daily lives across Europe.