Dermatology
Plaque Psoriasis
Goals and Benefits of Topical Therapy for Psoriasis
Topical corticosteroids are a cornerstone of treatment for psoriasis, but long-term use can be associated with adverse events and other treatment challenges. Recent information from Maui Derm Hawaii 2025 provided some insights into potential new directions for topical psoriasis treatment.
Following these presentations, featured expert Linda Stein Gold, MD, was interviewed by Conference Reporter Associate Editor-in-Chief Rick Davis. Dr Stein Gold’s clinical perspectives on these findings are presented here.
The majority of our patients are using topical therapy to control their psoriasis, either alone or in combination with systemic therapy. Traditionally, we used topical steroids alone or with other topical drugs such as calcipotriene or tazarotene. However, the potent steroids cannot be used for extended periods, and they are not appropriate for sensitive areas of the body. We know that side effects of topical steroids, such as atrophy and striae, occur, and striae are especially concerning because they are irreversible.
We need something that can simplify the treatment regimen. A lot of our patients with psoriasis are given many prescriptions (eg, something for the scalp, something for sensitive areas, something for flares, and something for maintenance). It becomes confusing. Sometimes these patients become incapacitated by fear because they do not remember the treatment regimen that was explained to them by their physician once they get home, or they use a potent steroid on their eyelids, groin, and everywhere else because it previously worked well on their elbows, which can lead to significant complications.
Fortunately, we now have some relatively new nonsteroidal options for the treatment of psoriasis that are highly effective and well tolerated. The first option is the AHR agonist tapinarof. It works inside the cell and downregulates proinflammatory cytokines, including IL-17. It also helps to improve the skin barrier. We studied a once-daily cream formulation of tapinarof as monotherapy for patients who had mild, moderate, and severe plaque psoriasis in 2 identical phase 3 trials (ie, PSOARING 1 and PSOARING 2). We found that up to approximately 40% of patients became clear or almost clear, with a 2-grade improvement in Physician Global Assessment score at week 12. It was also very well tolerated. Unlike topical vitamin D or vitamin A, which can cause stinging and burning, tapinarof caused minimal stinging and burning, especially in sensitive areas. The main dermatological side effects were folliculitis and contact dermatitis, but these were generally mild or moderate and often resolved by stopping treatment in that area.
We then conducted a long-term analysis in which patients who had completed the phase 3 studies could enter an open-label study for an additional 40 weeks (ie, PSOARING 3). Patients stayed on the medication until they were completely clear, and then we took their medication away and waited to see how long it took for them to develop mild disease or worse. On average, there was an approximately 4-month remittive effect, which was quite interesting. Tapinarof was also highly effective in intertriginous disease, as well as in head and neck psoriasis. This provides what I would consider “one-stop shopping.” We can give patients one medication that is safe and effective on all areas of the body, is used once per day, gets psoriasis under control, and keeps it under control.
The second relatively new nonsteroidal topical therapy for psoriasis is roflumilast cream 0.3%, a topical PDE4 inhibitor. It is much more potent than the PDE4 inhibitors that were previously available in dermatology. In the DERMIS-1 and DERMIS-2 trials, we studied roflumilast once daily for 8 weeks in individuals with mild, moderate, or severe plaque psoriasis. Up to 42% of patients got to clear or almost clear according to Investigator Global Assessment scores, and we found roflumilast to be highly effective for intertriginous psoriasis. Roflumilast was also very well tolerated. The most common adverse events were headache and diarrhea, which occurred more often when treating larger body surface areas.
We also conducted a long-term study of roflumilast in which patients could stop treatment as soon as their plaques cleared, but they had the autonomy to treat their psoriasis whenever it came back. So, patients went on and off treatment as needed. That is a different type of study design, but, by using the medication on and off, we found that 50% of patients could, on average, maintain clear or almost clear skin over a course of more than 10 months.
More recently, roflumilast foam 0.3% was US Food and Drug Administration (FDA) approved for seborrheic dermatitis and is being investigated for psoriasis of the scalp and body. Data from the phase 3 ARRECTOR trial presented at the recent Maui Derm Hawaii 2025 meeting showed that this formulation was highly effective for both scalp and body psoriasis. It makes sense to have a foam formulation for the scalp, and it is much easier for patients to be able to treat all body surface areas with just one medication, especially a nonsteroidal option, which allows us to simplify the treatment regimen and to better set our patients up for success.
Gooderham MJ, Bagel J, Forman SB, et al. Patient-reported outcomes with roflumilast foam 0.3% in patients with psoriasis of the scalp and body in the phase 3 ARRECTOR trial. Abstract presented at: Maui Derm Hawaii 2025; January 20-24, 2025; Maui, HI.
Grossmann MC, Pixley JN, Feldman SR. A review of topical tapinarof for the treatment of plaque psoriasis. Ann Pharmacother. 2024;58(1):76-85. doi:10.1177/10600280231164775
Lebwohl MG, Kircik LH, Moore AY, et al. Effect of roflumilast cream vs vehicle cream on chronic plaque psoriasis: the DERMIS-1 and DERMIS-2 randomized clinical trials. JAMA. 2022;328(11):1073-1084. doi:10.1001/jama.2022.15632
Lebwohl MG, Stein Gold L, Strober B, et al. Phase 3 trials of tapinarof cream for plaque psoriasis. N Engl J Med. 2021;385(24):2219-2229. doi:10.1056/NEJMoa2103629
Stein Gold L, Adam DN, Albrecht L, et al. Long-term safety and effectiveness of roflumilast cream 0.3% in adults with chronic plaque psoriasis: a 52-week, phase 2, open-label trial. J Am Acad Dermatol. 2024;91(2):273-280. doi:10.1016/j.jaad.2024.03.030
Strober B, Stein Gold L, Bissonnette R, et al. One-year safety and efficacy of tapinarof cream for the treatment of plaque psoriasis: results from the PSOARING 3 trial. J Am Acad Dermatol. 2022;87(4):800-806. doi:10.1016/j.jaad.2022.06.1171
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