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

Publication date: Available online 17 January 2018
Source:Allergologia et Immunopathologia
Author(s): E. Rubio-Gomis, I. Martinez-Mir, F.J. Morales-Olivas, A. Martorell-Aragones, V. Palop-Larrea, A. Bernalte-Sesé, J.C. Cerda-Mir, P. Polo-Martín, I. Febrer, L. Aranda-Grau, I. Llosa-Cortes, Mª.J. Tejedor-Sanz, J.C. Julia-Benito, T. Alvarez-de-Laviada-Mulero, Mª.V. 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. Felix-Toledo, D. Marmaneu-Laguia, V.E. Garcia-Martinez, Mª.A. Beltran-Marques, B. Rodriguez-Gracia
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.



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