Phase 3 Trial Data Indicates Roflumilast Foam Helpful for Seborrheic Dermatitis Patients

Andrew Blauvelt, MD, MBA

New research finds that roflumilast foam may lead to positive outcomes for seborrheic dermatitis (SD) patients. The study was led by Andrew Blauvelt, MD, MBA, of the Oregon Medical Research Center, and these findings are the finalized version of preliminary findings published previously on HCPLive.

SD is known as a common, chronic inflammatory skin disease affecting all ages and around 5% of the global, approximately. SD treatments such as antifungal agents and corticosteroids are known by dermatologists to have limitations such as side effects, which is why this study was conducted regarding roflumilast, a selective phosphodiesterase 4 (PDE4) inhibitor.

“Once-daily, nonsteroidal roflumilast foam 0.3% provided improvement across multiple efficacy endpoints versus vehicle in patients with SD in a phase 3 trial,” Blauvelt and colleagues wrote.

Background

The study’s investigators implemented a randomized, double-blind, parallel-group, vehicle-controlled trial, recruiting participants that were ≥9 years-of-age facing moderate-to-severe SD. Their SD cases affected both the scalp and non-scalp regions.

The researchers’ primary efficacy endpoint was decided as a rating by Week 8 (W8) of participants’ Investigator Global Assessment (IGA) Success. Specifically, these patients would have an IGA of either Clear or Almost Clear in addition to an improvement from baseline of ≥2.

Findings

The phase 3 trial concluded that by Week 8, significantly more participants treated with roflumilast than those who were vehicle-treated were able to achieve the primary efficacy endpoint of IGA Success and a Clear IGA status.

The investigators also reported that, compared to the vehicle group, substantially larger percentages of roflumilast-treated patients achieved secondary endpoints of:

• An overall Erythema score of 0 by W8
• An overall Scaling score of 0 by W8
• A WI-NRS Success score at W2, 4, and 8
• A strong local tolerability rating with investigator and patient assessments

The researchers found that even patients achieving IGA Success and IGA Clear at Weeks 2 and 4 were made up of higher percentages of the roflumilast-group than the vehicle-group.