6/29/23, 1:13 AM Roflumilast in SD Pathway Feedback Search Clinical Topics Home Studies Roflumilast in SD Roflumilast in SD Disease Seborrheic dermatitis Trial question What is the effect of roflumilast 0.3% foam in patients with seborrheic dermatitis? Study design Multi-center Double blinded RCT Population Characteristics of study participants 49.0% female N = 226 51.0% male 226 patients (110 female, 116 male) Inclusion criteria: adult patients with a clinical diagnosis of seborrheic dermatitis for 3 months and Investigator Global Assessment score of 3, affecting < = 20% of body, including scalp, face, trunk, and/or intertriginous areas Key exclusion criteria: use of topical antifungals; corticosteroids; topical calcineurin inhibitors; sulfur-based treatments; medical devices; crisaborole; azelaic acid or metronidazole 2 weeks before randomization Interventions N=154 roflumilast foam (once-daily topical application of 0.3% roflumilast in emollient foam) N=72 vehicle foam (once-daily topical application of vehicle foam without active ingredient) https://web.pathway.md/studies/recvctf1uNTxjHdmG 1/2 6/29/23, 1:13 AM Roflumilast in SD Pathway Primary outcome Investigator Global Assessment success at week 8 73.8 % 73.8 55.3 % 40.9 36.9 % Significant increase 18.4 % NNT = 3 0.0 % Roflumilast foam Vehicle foam Significant increase in Investigator Global Assessment success at week 8 (73.8% vs. 40.9%; AD 32.8%, 95% CI 18.5 to 45.7) Secondary outcomes Significant increase in Investigator Global Assessment success at week 2 (33.8% vs. 14.7%; AD 19.1%, 95% CI 6.6 to 29.3) Significant increase in erythema success at week 8 (44.7% vs. 21.2%; AD 23.5%, 95% CI 9.6 to 35) Significant increase in Worst Itch NRS success (64.6% vs. 34%; AD 30.6%, 95% CI 14.4 to 44.6) Safety outcomes No significant difference in adverse events. Conclusion In adult patients with a clinical diagnosis of seborrheic dermatitis for 3 months and Investigator Global Assessment score of 3, affecting < = 20% of body, including scalp, face, trunk, and/or intertriginous areas, roflumilast foam was superior to vehicle foam with respect to Investigator Global Assessment success at week 8. Reference Matthew J Zirwas, Zoe D Draelos, Janet DuBois 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. 2023 May 3;e230846. Open reference URL https://web.pathway.md/studies/recvctf1uNTxjHdmG 2/2