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109 results

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Page 1
Roflumilast Cream, 0.15%, for Atopic Dermatitis in Adults and Children: INTEGUMENT-1 and INTEGUMENT-2 Randomized Clinical Trials.
Simpson EL, Eichenfield LF, Alonso-Llamazares J, Draelos ZD, Ferris LK, Forman SB, Gooderham M, Gonzalez ME, Hebert AA, Kircik LH, Lomaga M, Moore A, Papp KA, Prajapati VH, Hanna D, Snyder S, Krupa D, Burnett P, Almaraz E, Higham RC, Chu DH, Berk DR. Simpson EL, et al. JAMA Dermatol. 2024 Nov 1;160(11):1161-1170. doi: 10.1001/jamadermatol.2024.3121. JAMA Dermatol. 2024. PMID: 39292443 Free PMC article. Clinical Trial.
OBJECTIVE: To evaluate efficacy and safety of once-daily roflumilast cream, 0.15%, vs vehicle cream in patients with AD. DESIGN, SETTING, AND PARTICIPANTS: Two phase 3, randomized, double-blind, vehicle-controlled trials (Interventional Trial Evaluating Roflumilast …
OBJECTIVE: To evaluate efficacy and safety of once-daily roflumilast cream, 0.15%, vs vehicle cream in patients with AD. DESIGN, SETT …
Roflumilast Foam, 0.3%, for Psoriasis of the Scalp and Body: The ARRECTOR Phase 3 Randomized Clinical Trial.
Gooderham MJ, Alonso-Llamazares J, Bagel J, Bhatia N, Bukhalo M, DuBois J, Ferris LK, Green L, Kircik LH, Lockshin B, Loo WJ, Papp KA, Soung J, Seal MS, Snyder S, Kato S, Krupa D, Burnett P, Berk DR, Chu DH. Gooderham MJ, et al. JAMA Dermatol. 2025 Jul 1;161(7):698-706. doi: 10.1001/jamadermatol.2025.1136. JAMA Dermatol. 2025. PMID: 40332898 Free PMC article. Clinical Trial.

RESULTS: A total of 432 patients (mean [SD] age, 47.3 [14.8] years; 243 women [56.3%]) were randomized to roflumilast foam (n = 281) or vehicle (n = 151). At week 8, 66.4% of the roflumilast group achieved S-IGA success vs 27.8% of the vehicle group (P < .001); a

…
RESULTS: A total of 432 patients (mean [SD] age, 47.3 [14.8] years; 243 women [56.3%]) were randomized to roflumilast foam (n = 281) …
Roflumilast foam 0.3% for adolescent and adult patients with seborrheic dermatitis: A randomized, double-blinded, vehicle-controlled, phase 3 trial.
Blauvelt A, Draelos ZD, Stein Gold L, Alonso-Llamazares J, Bhatia N, DuBois J, Forman SB, Gooderham M, Green L, Guenthner ST, Hebert AA, Lain E, Moore AY, Papp KA, Zirwas M, Kato S, Snyder S, Krupa D, Burnett P, Berk DR, Chu DH. Blauvelt A, et al. J Am Acad Dermatol. 2024 May;90(5):986-993. doi: 10.1016/j.jaad.2023.12.065. Epub 2024 Jan 20. J Am Acad Dermatol. 2024. PMID: 38253129 Free article. Clinical Trial.
BACKGROUND: The topical phosphodiesterase 4 inhibitor roflumilast has been studied in several dermatologic conditions. OBJECTIVE: Roflumilast foam 0.3% is being investigated as a topical treatment for seborrheic dermatitis (SD). ...Safety was also assessed. RESULTS: …
BACKGROUND: The topical phosphodiesterase 4 inhibitor roflumilast has been studied in several dermatologic conditions. OBJECTIVE: …
Efficacy and Safety of Once-Daily Roflumilast Cream 0.05% in Pediatric Patients Aged 2-5 Years With Mild-to-Moderate Atopic Dermatitis (INTEGUMENT-PED): A Phase 3 Randomized Controlled Trial.
Eichenfield LF, Serrao R, Prajapati VH, Browning JC, Swanson L, Funk T, Gonzalez ME, Hebert AA, Lee M, Boguniewicz M, Simpson EL, Seal MS, Krupa D, Hanna D, Snyder S, Burnett P, Chu DH, Almaraz E, Higham RC, Berk DR. Eichenfield LF, et al. Pediatr Dermatol. 2025 Mar-Apr;42(2):296-304. doi: 10.1111/pde.15840. Epub 2025 Feb 20. Pediatr Dermatol. 2025. PMID: 39980188 Free PMC article. Clinical Trial.
This Phase 3 parallel-group, double-blind trial (INTEGUMENT-PED; NCT04845620) compared the efficacy and safety of roflumilast cream 0.05% and a vehicle in patients aged 2-5 years with AD. METHODS: Patients aged 2-5 years with mild-to-moderate AD were treated with once-dail …
This Phase 3 parallel-group, double-blind trial (INTEGUMENT-PED; NCT04845620) compared the efficacy and safety of roflumilast cream 0 …
Effect of roflumilast on exacerbations in patients with severe chronic obstructive pulmonary disease uncontrolled by combination therapy (REACT): a multicentre randomised controlled trial.
Martinez FJ, Calverley PM, Goehring UM, Brose M, Fabbri LM, Rabe KF. Martinez FJ, et al. Lancet. 2015 Mar 7;385(9971):857-66. doi: 10.1016/S0140-6736(14)62410-7. Epub 2015 Feb 13. Lancet. 2015. PMID: 25684586 Clinical Trial.
BACKGROUND: Roflumilast reduces exacerbations in patients with severe chronic obstructive pulmonary disease. ...Adverse events were reported by 648 (67%) of 968 patients receiving roflumilast and by 572 (59%) of 967 patients in the placebo group; adverse event-assoc …
BACKGROUND: Roflumilast reduces exacerbations in patients with severe chronic obstructive pulmonary disease. ...Adverse events were r …
Oral Roflumilast Suppresses Proinflammatory Cytokine Signaling and Reduces CD4+ T-Cell and Neutrophil Infiltration in Psoriasis.
Baez E, Gyldenløve M, Ben Abdallah H, Emmanuel T, Sørensen JA, Thomsen SF, Zachariae C, Egeberg A, Skov L, Iversen L, Johansen C. Baez E, et al. J Invest Dermatol. 2025 Dec;145(12):3079-3088.e3. doi: 10.1016/j.jid.2025.04.034. Epub 2025 May 20. J Invest Dermatol. 2025. PMID: 40403838 Free article. Clinical Trial.
Oral roflumilast is a phosphodiesterase-4 inhibitor approved for the treatment of chronic obstructive pulmonary disease. ...This substudy investigated the cellular and molecular effects of oral roflumilast treatment on psoriatic skin in vivo. In the PSORRO (Psoriasi …
Oral roflumilast is a phosphodiesterase-4 inhibitor approved for the treatment of chronic obstructive pulmonary disease. ...This subs …
Long-Term Safety and Efficacy of Roflumilast Foam 0.3% in Patients with Seborrheic Dermatitis: A Phase II, Open-Label Trial of up to 52 Weeks.
Alexis AF, Bukhalo M, Cook-Bolden FE, Del Rosso JQ, Draelos ZD, DuBois JC, Ferris LK, Forman SB, Kempers SE, Kircik LH, Lain E, Moore AY, Pariser DM, Raoof J, Zirwas MJ, Seal MS, Kato S, Chu DH, Krupa D, Snyder S, Burnett P, Berk DR. Alexis AF, et al. Am J Clin Dermatol. 2026 Jan;27(1):189-198. doi: 10.1007/s40257-025-00984-2. Epub 2025 Nov 1. Am J Clin Dermatol. 2026. PMID: 41175336 Free PMC article. Clinical Trial.
BACKGROUND: The efficacy and safety of once-daily roflumilast foam 0.3%, a potent phosphodiesterase 4 inhibitor, has been demonstrated in patients with seborrheic dermatitis (SD). OBJECTIVES: To evaluate long-term effects of roflumilast foam 0.3% in patients with SD …
BACKGROUND: The efficacy and safety of once-daily roflumilast foam 0.3%, a potent phosphodiesterase 4 inhibitor, has been demonstrate …
Effect of Roflumilast and Inhaled Corticosteroid/Long-Acting beta2-Agonist on Chronic Obstructive Pulmonary Disease Exacerbations (RE(2)SPOND). A Randomized Clinical Trial.
Martinez FJ, Rabe KF, Sethi S, Pizzichini E, McIvor A, Anzueto A, Alagappan VK, Siddiqui S, Rekeda L, Miller CJ, Zetterstrand S, Reisner C, Rennard SI. Martinez FJ, et al. Am J Respir Crit Care Med. 2016 Sep 1;194(5):559-67. doi: 10.1164/rccm.201607-1349OC. Am J Respir Crit Care Med. 2016. PMID: 27585384 Clinical Trial.
However, roflumilast improved lung function, and in a post hoc analysis roflumilast significantly reduced the rate of moderate or severe exacerbations in participants with a history of more than three exacerbations and/or one or more hospitalizations in the prior ye …
However, roflumilast improved lung function, and in a post hoc analysis roflumilast significantly reduced the rate of moderate …
Early Evidence of Safety, Clinical Benefit, and Pharmacokinetics of Roflumilast Cream 0.3% Once Daily for Treatment of Mild or Moderate Plaque Psoriasis in Children Aged 2-11 Years.
Hebert AA, Guide SV, Groysman V, Gonzalez ME, Blanco D, Laquer V, Seal MS, Thurston A, Krupa D, Snyder S, Burnett P, Chu DH, Berk DR, Higham RC. Hebert AA, et al. Pediatr Dermatol. 2026 Jan-Feb;43(1):105-108. doi: 10.1111/pde.70013. Epub 2025 Aug 27. Pediatr Dermatol. 2026. PMID: 40862624 Free PMC article. Clinical Trial.
Evidence of systemic exposure to roflumilast and its active N-oxide metabolite was seen in most patients following daily application, consistent with previous studies. Under maximal use conditions, once-daily roflumilast cream 0.3% was well tolerated and improved si …
Evidence of systemic exposure to roflumilast and its active N-oxide metabolite was seen in most patients following daily application, …
Efficacy of Roflumilast Foam, 0.3%, in Patients With Seborrheic Dermatitis: A Double-blind, Vehicle-Controlled Phase 2a Randomized Clinical Trial.
Zirwas MJ, Draelos ZD, DuBois J, Kircik LH, Moore AY, Stein Gold L, Alonso-Llamazares J, Bukhalo M, Bruce S, Eads K, Green LJ, Guenthner ST, Ferris LK, Forman SB, Kempers SE, Lain E, Lynde CW, Pariser DM, Toth DP, Yamauchi PS, Higham RC, Krupa D, Burnett P, Berk DR. Zirwas MJ, et al. JAMA Dermatol. 2023 Jun 1;159(6):613-620. doi: 10.1001/jamadermatol.2023.0846. JAMA Dermatol. 2023. PMID: 37133856 Free PMC article. Clinical Trial.
RESULTS: A total of 226 patients (mean [SD] age, 44.9 [16.8] years; 116 men, 110 women) were randomized to roflumilast foam (n = 154) or vehicle foam (n = 72). At week 8, 104 (73.8%) roflumilast-treated patients achieved IGA success compared with 27 (40.9%) in the v …
RESULTS: A total of 226 patients (mean [SD] age, 44.9 [16.8] years; 116 men, 110 women) were randomized to roflumilast foam (n = 154) …
109 results