2015 Randomized Controlled, Double Blind Trial of Topical Twice Weekly Fluticasone Propionate Maintenance Treatment to Reduced Risk of Relapse in Mild or Moderate Atopic Dermatitis in Children

Saturday, 8 December 2012
Hall 4 (HICC)

Elena Rubio, MD, Phd , Clinical Pharmacology Unit, Hospital, Valencia, Spain

Inocencia Martinez-Mir, PhD , Dirección Médica-Fundación Hgu, Chguv, Valencia, Valencia, Spain

Francisco J Morales-Olivas, PhD , Departamento Farmacología, Universitat De Valéncia, Valencia, Spain

Antonio Martorell-Aragonés, PhD , Unidad De Alergía Pediátrica, Chguv, Valencia, Spain

Vicente Palop Larrea, PhD , Subdirección Médica Asistencial, Departamento De Salud La Ribera, Valencia, Spain

Alejandro Bernalte Sesé , Servicio De Farmacia, Chguv, Valencia, Spain

Juan C Cerdá Mir, MD , Unidad De Alergía Pediátrica, Chguv, Valencia, Spain

Pedro Polo Martín, PhD , Centro De Salud (CS) Barrio De La Luz, Xirivella, Valencia, Xirivella, Spain

Isabel Febrer, PhD , Servicio Dermatología, Chguv, Valencia, Spain

Laura Aranda Grau, PhD , Centro De Atención Primaria De Pobla De Vallbona. Valencia, Valencia, Spain

Inmaculada Llosa Cortes, MD , CS Monserrat, Valencia, Monserrat, Spain

María José Tejedor Sanz, MD , CS Torrente II, Valencia, Torrent, Spain

Juan C Juliá Benito, PhD , CS Alzira, Valencia, Alzira, Spain

Teresa Álvarez De Laviada, PhD , Centro De Salud (CS) Barrio De La Luz, Xirivella, Valencia, Xirivella, Spain

María Victoria Planelles Cantarino, MD , CS Paiporta, Valencia, Paiporta, Spain

Esther Apolinar Valiente, PhD , CS Torrente I, Valencia, Torrent, Spain

Mercedes Loriente Tur, MD , CS Alacuas, Valencia, Alacuas, Spain

Antonio M Abella Bazataqui, PhD , Centro De Atención Primaria De Pobla De Vallbona, Valencia, Pobla de Vallbona, Spain

Irene Álvarez Gonzalez, MD , CS Burjasot II, Valencia, Burjasot, Spain

Cristina Morales-Carpi, PhD , CS Picasent, Valencia, Picasent, Spain

Maria Enrriqueta Burches Greu, PhD , CS Xirivella, Valencia, Xirivella, Spain

Ana B Ferrer Bautista, MD , CS Paiporta, Valencia, Paiporta, Spain

Raúl Felix Toledo, PhD , Unidad De Alergía Pediátrica, Chguv, Valencia, Spain

Dolores Marmeneu Laguia, MD , CS Alacuas, Valencia, Alacuas, Spain

Victoria E Garcia-Martinez, MD , CS Alacuas, Valencia, Alacuas, Spain

María Antonia Beltran Marques, MD , CS Torrente I, Valencia, Torrente, Spain

María Begoña Rodriguez Gracia, MD , CS Auxiliar El Vedat De Torrent, Valencia, Torrent, Spain

Inocencia Martinez-Mir, PhD , Dirección Médica-Fundación Hgu, Chguv, Valencia, Valencia, Spain

Background: One of the most troublesome features of atopic dermatitis (AD) is its chronic relapsing nature.  The long-term efficacy and potential of corticosteroids to reduce or prevent relapses have only partially been addressed, especially in children. This study was designed to compare an intermittent dosing regimen of fluticasone propionate (FP) cream 0.05% (twice per week) with its vehicle base in reducing the risk of relapse in paediatric subjects with stabilized AD

Methods: Randomized controlled, multicentric, double blind trial was conducted. Severity of AD was scored by means of the modified Scoring of Atopic Dermatitis system (SCORAD). Children (2-10 years) with mild or moderate AD (SCORAD up to 50; exclusion criteria were >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 children who achieved treatment success (SCORAD<5or≥75% initial SCORAD) 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 of AD, time to relapse and severity of disease were also studied. Kaplan–Meier estimates were calculated to describe the time to relapse distribution. The study protocol was approved by the Ethics Committee and all patients’ parents provided their written informed consent.

Results: Fifty-four patients (29girls) entered the OSP (23 mild AD) and 49 (26girls) continued into the DMP. Mean age was 5.5 (SD2.8) and 5.1 (SD2.3) yrs for FP and vehicle groups, respectively. Four patients withdrew from the DMP (two in the FP group and two in the vehicle 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, SE1.28; p=0.034). FP was also superior to vehicle for delaying time to relapse (Mean 108.4 SD32.5 and Mean 77.4 SD54.6, respectively). Therapy with both treatments was well tolerated

Conclusions: This long-term study shows that twice per week FP provides an effective maintenance treatment regimen to control AD through a significantly reduction of the risk of relapse in children with mild and moderate AD

Grant ISCIII EC08/00004