| Affiliation: | 1. Unidad de Farmacología Clínica, Consorcio Hospital General Universitario de Valencia CHGUV, Valencia, Spain;2. Departamento Farmacología, Universitat de Valéncia, Valencia, Spain;3. Dirección Gerencia-Fundación HGU, CHGUV, Valencia, Spain;4. Unidad de Alergía Pediátrica, CHGUV, Valencia, Spain;5. Subdirección Médica Asistencial, Departamento de Salud La Ribera, Alzira, Valencia, Spain;6. Servicio de Farmacia, CHGUV, Valencia, Spain;g. Centro de Salud (CS) Barrio de la Luz, Xirivella, Valencia, Spain;h. Servicio Dermatología, CHGUV, Valencia, Spain;i. Centro de Atención Primaria de Pobla de Vallbona, Valencia, Spain;j. CS Monserrat, Valencia, Spain;k. CS Torrente II, Valencia, Spain;l. CS Alzira, Valencia, Spain;m. CS Paiporta, Valencia, Spain;n. CS Torrente I, Valencia, Spain;o. CS Alacuas, Valencia, Spain;p. CS Burjasot II, Valencia, Spain;q. CS Picasent, Valencia, Spain;r. CS Xirivella, Valencia, Spain;s. CS Auxiliar El Vedat de Torrent, Valencia, Spain |
| Abstract: | BackgroundThe 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.MethodsA 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.ResultsFifty-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.ConclusionThis long-term study shows that twice weekly FP provides an effective maintenance treatment to control the risk of relapse in children with AD. |
