Roflumilast Foam 0.3% Effective for Scalp, Body Psoriasis in Phase 3 Trial

A phase 3 study presented at the SDPA Annual Summer Dermatology Conference in Washington, DC, from June 25 to June 29th, demonstrated the effectiveness of once-daily roflumilast foam 0.3% over 8 weeks for psoriasis of the scalp and body.¹

“Patients reported improvements in symptoms, as well as a reduction in how psoriasis symptoms impacted daily life,” wrote investigators, led by Melinda J. Gooderham, MD, from SKiN Centre for Dermatology in Canada.

Common topical therapies for psoriasis, such as corticosteroids and calcineurin inhibitors, may lead to adverse events. For instance, corticosteroids may cause systemic adverse events, such glaucoma and loss of vision, growth retardation in infants and children, among others.2 Calcineurin inhibitors can result in a burning or stinging sensation, which should only last for about 15 – 20 minutes; this adverse event can occur after applying the topical and should settle down within the first week of use.3

Along with the adverse events, topical therapies for psoriasis also have limitations on duration of use and restrictions for use in thin-skinned areas, depending on the topicals’ strength. Moreover, patients may experience application difficulties that could reduce their adherence.

In ARRECTOR, a phase 3, randomized, parallel-group, double-blind, vehicle-controlled, multicenter trial evaluated once-daily roflumilast foam 0.3% for 8 weeks in children aged ≥ 12 years and adult patients with psoriasis of the scalp and body. Roflumilast, a PDE4 inhibitor formulated as a water-based foam or cream, does not contain skin-irritating ethanol, propylene glycol, or fragrances.

The primary endpoints included Scalp-Investigator Global Assessment (S-IGA) and Body-Investigator Global Assessment (B-IGA) success at week 8. S-IGA success was indicated by scores 0 (clear) and 1 (almost clear), along with a ≥ 2 grade improvement from baseline when rated from clear (0) to severe (4). B-IGA success was a score of 0/1 plus ≥ 2 grade improvement from baseline when rated from clear (0) to severe (4).

Secondary endpoints included the proportion of patients with 0 or 1 on SI/WI-NRS, which measured itch on a scale of 0 (no itch) to 10 (worst itch imaginable), and PSSI-75 and PSSI-100, referring to ≥ 75% and 100% reduction in PSSI, respectively. Other secondary endpoints included PSD, a validated 16-item questionnaire evaluating itch, pain, and scaling; scalpDex, a validated 23-item survey assessing the quality of life in patients with scalp dermatitis; and DLQI. Investigators also assessed safety and application-site tolerability.

Eligibility criteria included having at least moderate scalp and mild body psoriasis, BSA ≤ 25% (≤ 20% non-scalp BSA), PSSI ≥ 6, ≥ 10% scalp involvement, and PASI ≥ 2. Participants were randomized 2:1 to receive roflumilast foam 0.3% (n = 281) or vehicle foam (n = 151%) for 8 weeks.

The arms had similar demographic and baseline disease characteristics, with most patients (81.9%) previously using topical corticosteroids for psoriasis of the scalp and body. The roflumilast foam and vehicle foam arm had a mean age of 48.6 and 45 years, 54.1% and 60.3% females, respectively. Both arms at baseline had a mean S-IGA of 3.1 and a B-IGA of 2.8.

The analysis showed patients well-tolerated roflumilast foam 0.3%, which was consistent with safety outcomes reported in previous trials of roflumilast cream 0.3% in patients with psoriasis. Treatment-related adverse events (TEAEs) were mild or moderate in the roflumilast (96%) and vehicle (92%) arms, with 5.7% and 2% considered related to the study treatment, respectively.

The most common TEAEs were headache, diarrhea, COVID-19, and nausea. Discontinuations due to TEAEs were similar between the arms: roflumilast (n = 5; 1.8%) and vehicle (n = 2; 1.3%).

At week 8, significantly more patients on roflumilast achieved S-IGA success, B-IGA success, SI-NRS/WI-NRS 0/1, PSSI-75/100, and improvement in PROs, compared with the control arm (P < .0001). Furthermore, investigators observed improvements in patient-reported Scalpdex and PSD component scores with roflumilast as early as week 2 and continued through week 8.

“This is also in line with significant improvement (P<0.05) in scalp itch (SI-NRS) and worst itch (WI-NRS) previously observed within 24 hours after the first application of roflumilast foam 0.3%,” investigators concluded.

References

1. Gooderham M, Alonso-Llamazares J, Bhatia N, et al. Roflumilast Foam 0.3% in Patients with Psoriasis of the Scalp and Body: Improvements in Patient-Reported Outcomes in the ARRECTOR Trial. Presented at 2025 SDPA in Washington DC from June 25 – June 29th.

2. 2 Dhar S, Seth J, Parikh D. Systemic side-effects of topical corticosteroids. Indian J Dermatol. 2014 Sep;59(5):460-4. doi: 10.4103/0019-5154.139874. PMID: 25284850; PMCID: PMC4171913.

3. Topical Calcineurin Inhibitors (TCIs). Eczema Society. https://eczema.org/information-and-advice/treatments-for-eczema/topical-calcineurin-inhibitors/. Accessed July 8, 2025.