15 May JAMA Dermatology Study Evaluates Nonsteroidal Roflumilast Foam for Seborrheic Dermatitis
MedicalResearch.com Interview with:
Matthew Zirwas, MD
Founder, Bexley Dermatology Research Clinic
Bexley, OH 43209
MedicalResearch.com: What is the background for this study? How does Roflumilast differ from other treatments for seb derm?
Response: Seborrheic dermatitis affects up to 5% of the population globally and can have major impacts on quality of life. Treatment regimens are often complicated given the association of seborrheic dermatitis to hair bearing areas of the body, requiring multiple treatments for different parts of the body. Our phase 2 study aimed to understand the efficacy and safety of once-daily roflumilast foam 0.3% in adults with seborrheic dermatitis on their scalp, face and trunk. Roflumilast foam is a selective and highly potent phosphodiesterase (PDE) 4 inhibition that is being studied for a range of inflammatory skin conditions.
MedicalResearch.com: What are the main findings?
Response: In this randomized phase 2 double-blind clinical trial that included 226 patients with seborrheic dermatitis, 73.8% of roflumilast-treated patients achieved Investigator Global Assessment success at week 8 compared with 40.9%in the vehicle group, with superiority achieved by the first baseline assessment at week 2. In addition, 35.5% of patients achieved an IGA status of clear. Nearly two-thirds of roflumilast treated patients who had baseline WI-NRS score of 4 or greater achieved a 4-point or greater improvement at week 8.
Roflumilast was well tolerated and demonstrated a favorable safety and tolerability profile. Rates of treatment-related treatment-emergent AEs, serious AEs, and AEs leading to discontinuation were low and generally comparable with vehicle.
MedicalResearch.com: What should readers take away from your report?
Response: Our study suggests that once-daily nonsteroidal roflumilast foam 0.3% has the potential to meet the unmet need for an effective, cosmetically tolerable treatment for seborrheic dermatitis – a single product appropriate for all body areas, including the scalp.
MedicalResearch.com: What recommendations do you have for future research as a results of this study?
Response: Future research should include a larger phase 3 clinical study, as well as a long-term study that goes beyond 8 weeks of treatment.
MedicalResearch.com: Is there anything else you would like to add? Any disclosures?
Response: This study further elucidated the high itch burden of patients with seborrheic dermatitis. The success rate for improvement in itch in this study population is noteworthy, given the relatively high baseline itch scores and because itch is a major complaint of patients impacted by the disease.
Zirwas MJ, Draelos ZD, DuBois J, et al. Efficacy of roflumilasat foam, 0.3%, in patients with seborrheic dermatitis. A double-blind, vehicle-controlled, phase 2a randomized controlled trial. JAMA Dermatol. Published online May 3, 2023. Doi:10.1001/jamadermatol.2023.0846
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