Fluticasone in mild to moderate atopic dermatitis relapse: A randomized controlled trial

• E. Rubio-Gomis ^[1] ; I. Martinez-Mir ^[1] ; F.J. Morales-Olivas ^[1] ; A. Martorell-Aragones ^[1] ; V. Palop-Larrea ^[2] ; A. Bernalte-Sesé ^[1] ; J.C. Cerda-Mir ^[1] ; P. Polo-Martín ^[3] ; I. Febrer ^[1] ; L. Aranda-Grau ^[4] ; I. Llosa-Cortes ^[5] ; Mª.J. Tejedor-Sanz ^[6] ; J.C. Julia-Benito ^[7] ; T. Alvarez-de-Laviada-Mulero ^[3] ; Mª.V. Planelles-Cantarino ^[8] ; E. Apolinar-Valiente ^[9] ; M. Loriente-Tur ^[10] ; A.M. Abella-Bazataqui ^[4] ; I. Alvarez-Gonzalez ^[11] ; C. Morales-Carpi ^[12] ; Mª.E. Burches-Greus ^[13] ; A.B. Ferrer-Bautista ^[8] ; R. Felix-Toledo ^[1] ; D. Marmaneu-Laguia ^[10] ; V.E. Garcia-Martinez ^[10] ; Mª.A. Beltran-Marques ^[9] ; B. Rodriguez-Gracia ^[14]
  1. [1] Hospital General Universitario de Valencia

     Hospital General Universitario de Valencia

     Valencia, España

     
  2. [2] Departamento de Salud La Ribera, España
  3. [3] Centro de Salud Barrio de la Luz, Xirivella, Valencia, España
  4. [4] Centro de Atención Primaria de Pobla de Vallbona, Valencia, España
  5. [5] CS Monserrat, Valencia, España
  6. [6] CS Torrente II, Valencia, España
  7. [7] CS Alzira, Valencia, España
  8. [8] CS Paiporta, Valencia, España
  9. [9] CS Torrente I, Valencia, España
  10. [10] CS Alacuas, Valencia, España
  11. [11] CS Burjasot II, Valencia, España
  12. [12] CS Picasent, Valencia, España
  13. [13] CS Xirivella, Valencia, España
  14. [14] CS Auxiliar El Vedat de Torrent, Valencia, España

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• Localización: Allergologia et immunopathologia: International journal for clinical and investigate allergology and clinical immunology, ISSN-e 1578-1267, ISSN 0301-0546, Vol. 46, Nº. 4, 2018, págs. 378-384
• Idioma: inglés
• Texto completo no disponible (Saber más ...)
• Resumen

  • Background The long-term efficacy of corticosteroids to prevent atopic dermatitis (AD) relapses has partially been addressed in children. This study compared an intermittent dosing regimen of fluticasone propionate (FP) cream 0.05% with its vehicle base in reducing the risk of relapse in children with stabilized AD.

    Methods A randomized controlled, multicentric, double-blind trial was conducted. Children (2–10 years) with mild/moderate AD (exclusion criteria: >30% affected body surface area and/or head) were enrolled into an Open-label Stabilization Phase (OSP) of up to 2 weeks on twice daily FP. Those who achieved treatment success entered the Double-blind Maintenance Phase (DMP). They were randomly allocated to receive FP or vehicle twice-weekly on consecutive days for 16 weeks. The primary study endpoint was relapse rate; time to relapse and severity of disease were also studied. Kaplan–Meier estimates were calculated.

    Results Fifty-four patients (29 girls) entered the OSP (23 mild AD) and 49 (26 girls) continued into the DMP. Mean age was 5.5 (SD: 2.8) and 5.1 (SD: 2.3) yrs for FP and vehicle groups, respectively. Four patients withdrew from the DMP (two in every group). Patients treated with FP twice weekly had a 2.7 fold lower risk of experiencing a relapse than patients treated with vehicle (relative risk 2.72, SD: 1.28; p = 0.034). FP was also superior to vehicle for delaying time to relapse. Both treatment therapies were well tolerated.

    Conclusion This long-term study shows that twice weekly FP provides an effective maintenance treatment to control the risk of relapse in children with AD.