Two is Not Always Better Than One: The Efficacy of Roflumilast in Treating Seborrheic Dermatitis

Original Article: Efficacy of Roflumilast Foam, 0.3%, in Patients With Seborrheic Dermatitis: A Double-blind, Vehicle-Controlled Phase 2a Randomized Clinical Trial

What are the key takeaways of this article?

This study aimed to quantify the safety and efficacy of non-steroidal Roflumilast Foam (0.3%) for patients suffering from Seborrheic Dermatitis (SD). SD is an inflammatory skin reaction resultant of inflammation at the sebaceous glands, thought to be of multifactorial causes including reaction to Malassezia and sebum production due to hormonal and environmental influences.

Using a double-blind, randomized clinical trial, researchers found that the safety and efficacy of Roflumilast foam was favourable. In fact, the use of once-daily Roflumilast (0.3%) was tolerable and efficacious in treating the itch, erythema, and scaling that are secondary to SD. Currently, the standard treatment of SD includes multiple agents, such as antifungals, anti-inflammatories, and steroids. Using the Investigator Global Assessment (IGA), researchers found that 73.8% of patients treated with Roflumilast achieved success in comparison to 40.9% of patients in the vehicle group.

To conduct this study, 226 patients over the age of 18 with a clinical diagnosis of SD were followed from 24 sites across Canada and the United States. The clinical diagnosis of SD had to be present for more than 3 months in patients with an IGA score greater than 3 with disease affecting more than 20% of body surface area (BSA). Patients were treated for 8 weeks with a 1-week follow-up. Success was defined as an IGA score of 0 (clear) or 1 (almost clear) or a 2-grade improvement on a scale of 0-4(3 - moderate, 4 - severe). Similarly, success was also defined as a 4-point improvement using the Worst Itch Numeric Rating Scale (WI-NRS) with 0 being no itch and 10 the worst itch imaginable. Patients were also monitored for safety using adverse events (AE). The Patient Health Questionnaire Depression scale (PHQ-8) and Columbia-Suicide Severity Rating Scale (C-SSRS) were also used as a variable of success.

At baseline, more than 90% of patients had an IGA score of 3 or greater. 73.8% of patients treated with Roflumilast achieved success in comparison to 40.9% of patients in the vehicle group. There was a statistically significant improvement of erythema in patients treated with Roflumilast (44.7% vs. 21.2% in the vehicle group). Similarly, patients treated with Roflumilast achieved scaling success (56.0% vs 27.2% in the vehicle group). At week 8 of treatment, those receiving Roflumilast had greater improvements in WI-NRS score (64.6% compared to 34.0% in the vehicle group).

All patients were monitored for AE. Although those treated with Roflumilast Foam experienced a low rate of AE (24%), it was higher than the vehicle group (18.1%). Overall, two patients prematurely discontinued Roflumilast treatment as a result of migraine and site application pain. Related AE in patients using Roflumilast Foam included application site pain, diarrhea and insomnia. There were also rates of response seen in the vehicle group but this was explained by the use of ceramide-containing moisturizers in the vehicle group.

In conclusion, treatment with Roflumilast Foam 0.3% showed to be efficacious and safe with consistent improvement in primary markers set out by investigators. In comparison to the current standard of treatment for SD, Roflumilast decreases the number of products needed, including steroids, and shows potential for antifungal effects by inhibiting PDE activity in yeast.

Publication Date: July 3rd, 2023

Reference: Zirwas MJ, Draelos ZD, DuBois J, Kircik LH, Moore AY, Gold LS, Alonso-Llamazares J, Bukhalo M, Bruce S, Eads K, Green LJ. Efficacy of Roflumilast Foam, 0.3%, in Patients With Seborrheic Dermatitis: A Double-blind, Vehicle-Controlled Phase 2a Randomized Clinical Trial. JAMA dermatology. 2023 May 3.

Summary By: McKenzie Van Eaton