Resumen de Fluticasone in mild to moderate atopic dermatitis relapse: A randomized controlled trial
Elena Rubio Gomis, I. Martínez Mir, Francisco Morales Olivas, Antonio Martorell Aragonés, Vicente Palop Larrea, Alejandro Bernalte Sesé, Juan Carlos Cerdá Mir, P. Polo Martín, Isabel Febrer Bosch, L. Aranda Grau, I. Llosa Cortes, Mª.J. Tejedor Sanz, J.C. Juliá Benito, T. Alvarez de Laviada, M. Victoria Planelles Cantarino, E. Apolinar Valiente, M. Loriente Tur, A.M. Abella Bazataqui, I. Alvarez Gonzalez, C. Morales-Carpi, Mª.E. Burches Greus, A.B. Ferrer Bautista, R. Félix Toledo, D. Marmaneu Laguia, V.E. Garcia Martinez, Mª.A. Beltran Marques, B. Rodriguez Gracia
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.
