Roflumilast Foam as a Promising Topical Treatment for Scalp and Body Psoriasis: Phase 3 ARRECTOR Trial
Canada: In a major development for topical psoriasis therapy, researchers have found that roflumilast foam, 0.3%, applied once daily, significantly improves symptoms in patients with scalp and body psoriasis. The findings from the ARRECTOR Phase 3 randomized clinical trial, published in JAMA Dermatology, highlight both the efficacy and safety of the formulation in adolescents and adults.
The ARRECTOR trial, a double-blind, vehicle-controlled study, enrolled 432 participants aged 12 years and older. The participants presented with plaque psoriasis affecting up to 25% of the body, including a minimum of 10% scalp involvement. Conducted across 49 sites in the United States and Canada, the trial ran from August 2021 to June 2022.
Participants were randomly assigned to receive either roflumilast foam or a placebo (vehicle) once daily for eight weeks. The trial's co-primary endpoints were based on the Scalp Investigator Global Assessment (S-IGA) and Body IGA (B-IGA), which measured the percentage of patients who achieved either a "clear" or "almost clear" status along with a minimum two-grade improvement from baseline.
Key findings were as follows:
- By week 8, 66.4% of patients treated with roflumilast foam achieved Scalp Investigator Global Assessment (S-IGA) success, compared to 27.8% in the vehicle group.
- Body Investigator Global Assessment (B-IGA) success was achieved by 45.5% of the roflumilast group versus 20.1% in the placebo group.
- These results were statistically significant, indicating the strong efficacy of roflumilast foam.
- Itch relief was measured using the Scalp Itch Numeric Rating Scale (SI-NRS) and Worst Itch NRS (WI-NRS).
- There were significant improvements in itch as early as 24 hours after the first application of roflumilast foam.
- The improvements in itch persisted through weeks 2, 4, and 8, with the roflumilast group consistently showing better outcomes than the control group.
- Both groups experienced low rates of adverse events, and roflumilast was well tolerated.
- There were no new safety concerns, highlighting the favorable safety profile of roflumilast foam.
- The findings are significant, especially since existing topical treatments for scalp psoriasis often have limitations concerning tolerability, formulation, and long-term use.
The researchers note that roflumilast is a phosphodiesterase-4 (PDE-4) inhibitor, which targets inflammatory pathways central to psoriasis pathogenesis. Its foam formulation allows for easier application on hairy areas like the scalp, addressing one of the common barriers to patient adherence in topical treatment regimens.
"Overall, the findings support roflumilast foam, 0.3%, as a viable and convenient monotherapy for managing mild to moderate psoriasis involving both the scalp and body. With its promising efficacy, rapid symptom relief, and favorable safety profile, this treatment could represent a significant step forward in dermatologic care," they concluded.
Reference:
Gooderham MJ, Alonso-Llamazares J, Bagel J, et al. Roflumilast Foam, 0.3%, for Psoriasis of the Scalp and Body: The ARRECTOR Phase 3 Randomized Clinical Trial. JAMA Dermatol. Published online May 07, 2025. doi:10.1001/jamadermatol.2025.1136
