Roflumilast Foam Found Safe and Effective for Seborrheic Dermatitis Treatment: JAMA

A recent clinical trial published in JAMA: Dermatology has shown promising results for roflumilast foam as a nonsteroidal topical treatment option for seborrheic dermatitis.

Topical treatments for seborrheic dermatitis are currently limited in efficacy or safety. The purpose of the study was to evaluate the safety and efficacy of 0.3% roflumilast foam in adult patients with seborrheic dermatitis of the scalp, face, and/or trunk.

The multicenter phase 2a, parallel-group, double-blind, vehicle-controlled trial involved 226 adult patients with a clinical diagnosis of seborrheic dermatitis affecting the scalp, face, and/or trunk. The participants were randomly assigned to either once-daily application of roflumilast foam or vehicle foam for 8 weeks.

The primary outcome of the study was Investigator Global Assessment (IGA) success, which was defined as achieving an IGA score of clear or almost clear plus 2-grade improvement from baseline at week 8.

The study revealed the following clinical findings:

1. 154 patients received roflumilast foam, while 72 received vehicle foam.

2. At week 8, 73.8% of roflumilast-treated patients achieved IGA success, compared with 40.9% in the vehicle group.

3. Roflumilast-treated patients had significantly higher rates of IGA success compared to the vehicle group at week 2.

4. Roflumilast foam resulted in a mean reduction in WI-NRS score of 59.3% at week 8, compared to 36.6% in the vehicle group.

5. Roflumilast was well-tolerated with similar adverse event rates to the vehicle foam.

“The results indicate that roflumilast foam, 0.3%, is a safe and effective nonsteroidal topical treatment option for seborrheic dermatitis affecting the scalp, face, and/or trunk. The treatment demonstrated favourable efficacy, safety, and local tolerability in the treatment of erythema, scaling, and itch caused by seborrheic dermatitis.” added the researchers of the study.

This study provides a promising avenue for the development of new and improved treatment options for seborrheic dermatitis. Further investigation into roflumilast foam is warranted as a potential alternative to currently limited treatment options for seborrheic dermatitis.

Reference:

Zirwas MJ, Draelos ZD, DuBois J, et al. Efficacy of Roflumilast Foam, 0.3%, in Patients With Seborrheic Dermatitis: A Double-blind, Vehicle-Controlled Phase 2a Randomized Clinical Trial. JAMA Dermatol. Published online May 03, 2023. doi:10.1001/jamadermatol.2023.0846