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
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Wiley
2025
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| author | Adelaide A. Hebert Shireen V. Guide Vlada Groysman Mercedes E. Gonzalez Daisy Blanco Vivian Laquer Melissa S. Seal Archie Thurston David Krupa Scott Snyder Patrick Burnett David H. Chu David R. Berk Robert C. Higham |
| author_facet | Adelaide A. Hebert Shireen V. Guide Vlada Groysman Mercedes E. Gonzalez Daisy Blanco Vivian Laquer Melissa S. Seal Archie Thurston David Krupa Scott Snyder Patrick Burnett David H. Chu David R. Berk Robert C. Higham Adelaide A. Hebert Shireen V. Guide Vlada Groysman Mercedes E. Gonzalez Daisy Blanco Vivian Laquer Melissa S. Seal Archie Thurston David Krupa Scott Snyder Patrick Burnett David H. Chu David R. Berk Robert C. Higham |
| collection | Wiley Open Access |
| contents | 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 Adelaide A. Hebert Shireen V. Guide Vlada Groysman Mercedes E. Gonzalez Daisy Blanco Vivian Laquer Melissa S. Seal Archie Thurston David Krupa Scott Snyder Patrick Burnett David H. Chu David R. Berk Robert C. Higham Pediatric Dermatology ABSTRACT Two 4‐week, phase 2, open‐label, maximal usage pharmacokinetic (PK) and safety studies of once‐daily roflumilast cream 0.3% (a potent phosphodiesterase 4 inhibitor) were conducted in children aged 2–5 years and 6–11 years with psoriasis. 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 signs and symptoms of psoriasis in children aged 2–11 years, consistent with phase 3 results in adults and adolescents. Trial Registration: Clinicaltrials.gov listing: 215: NCT04655313; 216: NCT04746911. 10.1111/pde.70013 http://creativecommons.org/licenses/by-nc/4.0/ |
| doi_str_mv | 10.1111/pde.70013 |
| format | Artículo Open Access |
| id | wiley_oa_10_1111_pde_70013 |
| institution | Wiley Open Access |
| license_str_mv | http://creativecommons.org/licenses/by-nc/4.0/ |
| publishDate | 2025 |
| publisher | Wiley |
| record_format | wiley_oa |
| spellingShingle | 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 Adelaide A. Hebert Shireen V. Guide Vlada Groysman Mercedes E. Gonzalez Daisy Blanco Vivian Laquer Melissa S. Seal Archie Thurston David Krupa Scott Snyder Patrick Burnett David H. Chu David R. Berk Robert C. Higham Pediatric Dermatology 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 Adelaide A. Hebert Shireen V. Guide Vlada Groysman Mercedes E. Gonzalez Daisy Blanco Vivian Laquer Melissa S. Seal Archie Thurston David Krupa Scott Snyder Patrick Burnett David H. Chu David R. Berk Robert C. Higham Pediatric Dermatology ABSTRACT Two 4‐week, phase 2, open‐label, maximal usage pharmacokinetic (PK) and safety studies of once‐daily roflumilast cream 0.3% (a potent phosphodiesterase 4 inhibitor) were conducted in children aged 2–5 years and 6–11 years with psoriasis. 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 signs and symptoms of psoriasis in children aged 2–11 years, consistent with phase 3 results in adults and adolescents. Trial Registration: Clinicaltrials.gov listing: 215: NCT04655313; 216: NCT04746911. 10.1111/pde.70013 http://creativecommons.org/licenses/by-nc/4.0/ |
| title | 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 |
| topic | Pediatric Dermatology |
| url | https://onlinelibrary.wiley.com/doi/10.1111/pde.70013 |