Fluticasone in mild to moderate atopic dermatitis relapse: A randomized controlled trial
Por:
Rubio-Gomis E, Martinez-Mir I, Morales-Olivas FJ, Martorell-Aragones A, Palop-Larrea V, Bernalte-Sesé A, Cerda-Mir JC, Polo-Martín P, Febrer I, Aranda-Grau L, Llosa-Cortes I, Tejedor-Sanz MJ, Julia-Benito JC, Alvarez-de-Laviada-Mulero T, Planelles-Cantarino MV, Apolinar-Valiente E, Loriente-Tur M, Abella-Bazataqui AM, Alvarez-Gonzalez I, Morales-Carpi C, Burches-Greus ME, Ferrer-Bautista AB, Felix-Toledo R, Marmaneu-Laguia D, Garcia-Martinez VE, Beltran-Marques MA and Rodriguez-Gracia B
Publicada:
1 jul 2018
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. (c) 2018 SEICAP. Published by Elsevier Espana, S.L.U. All rights reserved.
Filiaciones:
Rubio-Gomis E:
Unidad de Farmacología Clínica, Consorcio Hospital General Universitario de Valencia CHGUV, Valencia, Spain
Departamento Farmacología, Universitat de Valéncia, Valencia, Spain
Martinez-Mir I:
Dirección Gerencia-Fundación HGU, CHGUV, Valencia, Spain
Morales-Olivas FJ:
Departamento Farmacología, Universitat de Valéncia, Valencia, Spain
Martorell-Aragones A:
Unidad de Alergía Pediátrica, CHGUV, Valencia, Spain
:
Subdirección Médica Asistencial, Departamento de Salud La Ribera, Alzira, Valencia, Spain
Bernalte-Sesé A:
Servicio de Farmacia, CHGUV, Valencia, Spain
Cerda-Mir JC:
Unidad de Alergía Pediátrica, CHGUV, Valencia, Spain
Polo-Martín P:
Centro de Salud (CS) Barrio de la Luz, Xirivella, Valencia, Spain
Febrer I:
Servicio Dermatología, CHGUV, Valencia, Spain
Aranda-Grau L:
Centro de Atención Primaria de Pobla de Vallbona, Valencia, Spain
Llosa-Cortes I:
CS Monserrat, Valencia, Spain
Tejedor-Sanz MJ:
CS Torrente II, Valencia, Spain
Julia-Benito JC:
CS Alzira, Valencia, Spain
Alvarez-de-Laviada-Mulero T:
Centro de Salud (CS) Barrio de la Luz, Xirivella, Valencia, Spain
Planelles-Cantarino MV:
CS Paiporta, Valencia, Spain
Apolinar-Valiente E:
CS Torrente I, Valencia, Spain
Loriente-Tur M:
CS Alacuas, Valencia, Spain
Abella-Bazataqui AM:
Centro de Atención Primaria de Pobla de Vallbona, Valencia, Spain
Alvarez-Gonzalez I:
CS Burjasot II, Valencia, Spain
Morales-Carpi C:
CS Picasent, Valencia, Spain
Burches-Greus ME:
CS Xirivella, Valencia, Spain
Ferrer-Bautista AB:
CS Paiporta, Valencia, Spain
Felix-Toledo R:
Unidad de Alergía Pediátrica, CHGUV, Valencia, Spain
Marmaneu-Laguia D:
CS Alacuas, Valencia, Spain
Garcia-Martinez VE:
CS Alacuas, Valencia, Spain
Beltran-Marques MA:
CS Torrente I, Valencia, Spain
Rodriguez-Gracia B:
CS Auxiliar El Vedat de Torrent, Valencia, Spain
Open Access
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