Foam treatment rapidly relieves itch and clears stubborn scalp psoriasis lesions (2025)

Research led by the SKiN Center for Dermatology observed substantial clearance of scalp and body psoriasis and rapid itch reduction in patients treated with roflumilast foam, 0.3%. Findings indicated significantly higher rates of clinical improvement in scalp and body lesions among those receiving the active treatment compared to a placebo.

Plaque psoriasis, a chronic inflammatory skin condition, affects up to half of psoriasis patients on the scalp, where the presence of hair can complicate topical treatment application. Scalp psoriasis often presents with persistent itch and discomfort, symptoms that substantially affect quality of life regardless of disease severity.

Existing topical treatments, including creams and ointments, may be cosmetically unacceptable, incompatible with hair-bearing areas, or poorly tolerated, resulting in suboptimal adherence and limited therapeutic outcomes. Newer formulations, such as foams, offer potential advantages by providing uniform application across both scalp and body skin, yet data on efficacy and safety remain limited.

In the study, "Roflumilast Foam, 0.3%, for Psoriasis of the Scalp and Body," published in JAMA Dermatology, researchers conducted a double-blinded, placebo-controlled, randomized clinical trial to evaluate the efficacy and safety of roflumilast foam, 0.3%, in patients with plaque psoriasis affecting the scalp and body.

A total of 432 participants aged 12 years and older were enrolled at 49 sites in the United States and Canada. Randomization occurred in a 2:1 ratio to receive roflumilast foam or placebo foam (identical formulation minus active drug), applied once daily for eight weeks.

Primary endpoints assessed scalp and body lesion clearance, defined as a Scalp-Investigator Global Assessment score of 0 (clear) or 1 (almost clear) with a minimum two-grade reduction from baseline and a Body-Investigator Global Assessment score of 0 or 1 with the same degree of improvement, evaluated at week eight.

Secondary endpoints evaluated pruritus reduction using the Scalp Itch Numeric Rating Scale and Worst Itch Numeric Rating Scale. Patient-reported outcomes included the Psoriasis Scalp Severity Index and Psoriasis Area and Severity Index.

In all, 66.4% of participants receiving roflumilast foam achieved scalp clearance compared to 27.8% of those receiving placebo. Body lesion clearance was observed in 45.5% of the roflumilast group and 20.1% of the placebo group.

Pruritus reduction was reported as early as 24 hours after the first application, with 65.3% of roflumilast recipients achieving a 4-point or greater reduction in the Scalp Itch Numeric Rating Scale at week eight compared to 30.3% in the placebo group.

Treatment-emergent adverse events occurred more frequently in the roflumilast group (26.7%) compared to the placebo group (16.6%). Serious adverse events were infrequent and occurred at similar rates in both groups (0.7%).

Findings indicate that roflumilast foam may serve as a convenient, once-daily monotherapy for plaque psoriasis involving both scalp and body regions, particularly in cases where conventional formulations are poorly tolerated.

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