Novel easy-to-use foam formulation clears scalp psoriasis in one-third of patients

Roflumilast foam is an attractive novel topical treatment for scalp and body psoriasis with a fast onset of action and remarkable efficacy in a phase 2 study.

“Almost 80% of our patients have scalp psoriasis; itching and flaking are some of the most burdensome symptoms of psoriasis,” said Prof. Leon Kircik (Icahn School of Medicine at Mount Sinai Medical Center, USA) [1]. These symptoms can cause social embarrassment and have a high impact on quality of life.

Treatment of the scalp is difficult because the hair may limit the efficacy of creams and ointments [2]. Roflumilast is a potent, non-steroidal phosphodiesterase-4 inhibitor being investigated as a topical treatment for various dermatologic conditions. It is formulated in a moisturising foam that can be easily applied on the scalp and the body.

In the current double-blind, randomised, placebo-controlled phase 2 study (NCT04128007), patients (n=304) were randomised in a 2:1 ratio to treatment with roflumilast foam (0.3%) once daily or a vehicle. Included patients were ≥12 years old and had at least mild severity psoriasis on both scalp and body. “Therefore, to document improvement, these patients had to be clear,” Prof. Kircik explained. Patients received treatment for 8 weeks with visits at week 2, 4, and 8, plus 1 week post treatment. Primary endpoint was scalp success according to an Investigator Global Assessment (IGA), indicated by clear or almost clear skin with a ≥2-grade improvement from baseline.

Nearly 90% of patients completed the study. Most participants had moderate, 14.5% mild, and 9.0% severe scalp psoriasis. At baseline, body (B-)IGA was mild in 59.5% of patients. “Of our patients, 87% had a severity of >4 in an itch numerical rating scale (NRS),” Prof. Kircik emphasised.

At week 8, 59.1% of patients achieved scalp (S-)IGA success with roflumilast foam versus 11.4% with the vehicle (P<0.0001; see Figure). Significant efficacy could be already demonstrated at week 2. “Of note, 34% of patients achieved a totally clear scalp. There is a huge delta compared with the vehicle, which is unusual for topical treatment,” Prof. Kircik said.

Figure: Roflumilast foam significantly increased the percentage of patients with S-IGA success at week 8 (primary endpoint) [1]



In addition, 26% of patients receiving roflumilast foam achieved the secondary endpoint of clear B-IGA. The foam was also effective in alleviating pruritus, with 71% of patients achieving a 4-point response in the worst-itch NRS. Regarding safety, there was little difference between the vehicle and roflumilast: ≥99% of roflumilast and ≥98% of vehicle-treated patients had no evidence of irritation. “Scalp treatment with creams gets messy and most patients stop treatment. The foam application will be a welcome addition to our treatments,” concluded Prof. Kircik.

1. Kircik LH, et al. Once-daily roflumilast foam 0.3% for scalp and body psoriasis: A randomized, double-blind, vehicle-controlled phase 2b study. AAD VMX 2021, 23-25 April.
2. Blakely K, Gooderham M. Psoriasis (Auckl) 2016;6:33-40.

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Posted on 7 June 20217 June 2021