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