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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 …
Pharmacokinetics of Roflumilast Cream in Chronic Plaque Psoriasis: Data from Phase I to Phase III Studies.
Thurston AW Jr, Osborne DW, Snyder S, Higham RC, Burnett P, Berk DR. Thurston AW Jr, et al. Am J Clin Dermatol. 2023 Mar;24(2):315-324. doi: 10.1007/s40257-022-00741-9. Epub 2022 Nov 24. Am J Clin Dermatol. 2023. PMID: 36422852 Free PMC article. Clinical Trial.
Systemic exposure (C(trough) and AUC) of roflumilast and roflumilast N-oxide in two phase III trials (DERMIS-1, n = 245; DERMIS-2, n = 250) of roflumilast cream 0.3% for 8 weeks was assessed at Weeks 4 and 8. ...Roflumilast N-oxide concentrations were …
Systemic exposure (C(trough) and AUC) of roflumilast and roflumilast N-oxide in two phase III trials (DERMIS-1, n = 245; DERMI …
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 …
Efficacy and safety profile of roflumilast in a real-world experience.
Cilli A, Bal H, Gunen H. Cilli A, et al. J Thorac Dis. 2019 Apr;11(4):1100-1105. doi: 10.21037/jtd.2019.04.49. J Thorac Dis. 2019. PMID: 31179051 Free PMC article.
Real-world studies about the use of roflumilast are limited. Our aim was to assess the efficacy, safety and tolerability of roflumilast in the treatment of stable COPD, in a real-world setting. ...Sixteen (19.3%) patients discontinued roflumilast because of A …
Real-world studies about the use of roflumilast are limited. Our aim was to assess the efficacy, safety and tolerability of roflum …
Roflumilast for asthma: Safety findings from a pooled analysis of ten clinical studies.
Chervinsky P, Meltzer EO, Busse W, Ohta K, Bardin P, Bredenbröker D, Bateman ED. Chervinsky P, et al. Pulm Pharmacol Ther. 2015 Dec;35 Suppl:S28-34. doi: 10.1016/j.pupt.2015.11.003. Epub 2015 Nov 22. Pulm Pharmacol Ther. 2015. PMID: 26612545 Clinical Trial.
RESULTS: Headache was the most frequent AE with an incidence rate of 50 and 29.2 per 100 patient-years in the 500 mug roflumilast and placebo groups, respectively. ...Nausea and diarrhoea occurred in 28.7 and 28.3 per 100 patient-years in the 500 mug roflumilast …
RESULTS: Headache was the most frequent AE with an incidence rate of 50 and 29.2 per 100 patient-years in the 500 mug roflumilast …
Once-daily roflumilast foam 0.3% for scalp and body psoriasis: a randomized, double-blind, vehicle-controlled phase IIb study.
Kircik LH, Alonso-Llamazares J, Bhatia N, Bukhalo M, Devani AR, Draelos ZD, DuBois J, Gooderham MJ, Kempers SE, Lain E, Lee M, Moore A, Murrell DF, Papp KA, Pariser DM, Sinclair R, Zirwas M, Burnett P, Higham RC, Krupa D, Berk DR. Kircik LH, et al. Br J Dermatol. 2023 Sep 15;189(4):392-399. doi: 10.1093/bjd/ljad182. Br J Dermatol. 2023. PMID: 37279795 Free article. Clinical Trial.
Significant improvements were also seen for secondary endpoints, including body IGA success, Scalp Itch Numeric Rating Scale and the Psoriasis Scalp Severity Index. The safety of roflumilast was generally similar to vehicle. Patients treated with roflumilast experie …
Significant improvements were also seen for secondary endpoints, including body IGA success, Scalp Itch Numeric Rating Scale and the Psorias …
The Safety and Efficacy of Roflumilast Cream 0.15% and 0.05% in Patients With Atopic Dermatitis: Randomized, Double-Blind, Phase 2 Proof of Concept Study.
Gooderham M, Kircik L, Zirwas M, Lee M, Kempers S, Draelos Z, Ferris L, Jones T, Saint-Cyr Proulx E, Bissonnette R, Bhatia N, Koppel R, Guenthner S, Eads K, Welgus H, Merritt C, Elias M, Navale L, Higham R, Droege M, Berk D. Gooderham M, et al. J Drugs Dermatol. 2023 Feb 1;22(2):139-147. doi: 10.36849/JDD.7295. J Drugs Dermatol. 2023. PMID: 36745371 Clinical Trial.
OBJECTIVE: To assess safety and efficacy of roflumilast cream in patients with mild to moderate AD. METHODS: In this phase 2, proof of concept trial, patients (N=136) aged ≥12 years with AD were randomized to once-daily roflumilast cream 0.15%, roflumilast …
OBJECTIVE: To assess safety and efficacy of roflumilast cream in patients with mild to moderate AD. METHODS: In this phase 2, proof o …
Roflumilast Increases Bacterial Load and Dissemination in a Model of Pseudomononas Aeruginosa Airway Infection.
Kasetty G, Papareddy P, Bhongir RK, Egesten A. Kasetty G, et al. J Pharmacol Exp Ther. 2016 Apr;357(1):66-72. doi: 10.1124/jpet.115.229641. Epub 2016 Feb 10. J Pharmacol Exp Ther. 2016. PMID: 26865680 Free article.
Several proinflammatory cytokines decreased in roflumilast-treated mice but in neither the neutrophil-recruiting chemokine KC nor IL-6. These findings show that roflumilast treatment impairs host defense against P. aeruginosa in the airways, which may indicate that …
Several proinflammatory cytokines decreased in roflumilast-treated mice but in neither the neutrophil-recruiting chemokine KC nor IL- …
First-Line Combination of R-CHOP with the PDE4 Inhibitor Roflumilast for High-Risk DLBCL.
Duque AED, Ferrari PSSM, Ethiraj P, Jaafar C, Qiu Z, Holder K, Butler MJ, Huelgas-Morales G, Karnad A, Dahia PLM, Aguiar RCT. Duque AED, et al. Cancers (Basel). 2024 Nov 18;16(22):3857. doi: 10.3390/cancers16223857. Cancers (Basel). 2024. PMID: 39594812 Free PMC article.
These data suggested that combining roflumilast with R-CHOP may be beneficial in DLBCL. METHODS: We conducted a single-center, single-arm, open-label, phase 1 study of roflumilast in combination with the standard of care, R-CHOP (Ro+R-CHOP), in pathologically proven …
These data suggested that combining roflumilast with R-CHOP may be beneficial in DLBCL. METHODS: We conducted a single-center, single …
Population pharmacokinetic modelling of roflumilast and roflumilast N-oxide by total phosphodiesterase-4 inhibitory activity and development of a population pharmacodynamic-adverse event model.
Lahu G, Hünnemeyer A, Diletti E, Elmlinger M, Ruth P, Zech K, McCracken N, Facius A. Lahu G, et al. Clin Pharmacokinet. 2010 Sep;49(9):589-606. doi: 10.2165/11536600-000000000-00000. Clin Pharmacokinet. 2010. PMID: 20690782
Both roflumilast and its metabolite roflumilast N-oxide have anti-inflammatory properties that contribute to overall pharmacological activity. OBJECTIVES: To model the pharmacokinetics of roflumilast and roflumilast N-oxide, evaluate the influence of p …
Both roflumilast and its metabolite roflumilast N-oxide have anti-inflammatory properties that contribute to overall pharmacol …
15 results