Efficacy Study of Topical Twice Weekly Fluticasone Treatment to Reduce Relapse in Atopic Dermatitis in Children
The relapsing nature of atopic dermatitis (AD) presents a challenge for its long-term treatment. Efficacy and safety of corticosteroids have been proven in the acute treatment of AD, but not its efficacy and security to reduce or prevent relapses.
Objectives To investigate long-term management (16 weeks) of AD with fluticasone propionate (FP) 0,05% cream twice weekly in addition to an emollient (vehicle) after stabilization of an acute flare of AD with FP cream.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
|Official Title:||Randomised Controlled, Double Blind Trial of Topical Twice Weekly Fluticasone Propionate Maintenance Treatment to Reduce Risk of Relapse in Mild or Moderate Atopic Dermatitis in Children|
- Relapse in Atopic Dermatitis (AD). [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]The primary study end point will be probability of a relapse of AD occurring (the relapse rate of AD).
- Time to relapse [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]The number of days from start of the Fluticasone propionate treatment in Double-blind Maintenance Phase (DMP) until AD relapse.
- Incidence of relapse [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]The proportion of children experiencing a relapse of AD during DMP.
- severity of the relapse [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]Severity of AD was scored by means of the modified Scoring of Atopic Dermatitis system (SCORAD).The difference of SCORAD intensity between initial values, Open-label Stabilization Phase (OSP), and end values (end of DMP)
- Adverse events and adverse effects [ Time Frame: 22 weeks ] [ Designated as safety issue: Yes ]Safety was assessed by monitoring adverse events and adverse effects throughout the study.
- Therapeutic compliance [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]To describe the therapeutic compliance by means of the control of the drug used.
|Study Start Date:||December 2009|
|Study Completion Date:||March 2013|
|Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
Experimental: Fluticasone, cream
fluticasone propionate (FP) cream of 0.05%. The vehicle is:Base PFCO/W, Propyleneglycol and Water conservant.
Drug: Fluticasone, cream
Experimental Group: on treatment with twice weekly on consecutive days FP cream of 0.05% for 16 weeks or at relapse
Placebo Comparator: Placebo, cream
Vehicle cream is composed by Base PFCO/W, Propyleneglycol and Water conservant.
Control Group: on treatment with twice weekly on consecutive days vehicle cream for 16 weeks or at relapse.
Patients 2-10 years of age with a history of mild to moderate AD will be eligible for this multicentre, randomized, double-blind, controlled study if they present an acute flare of AD (<30% affected body surface area; no head). After successful treatment of the flare in an acute phase, patients will receive either, FP twice weekly plus vehicle or vehicle alone over a 16-week maintenance phase. The primary study end point will be probability of a relapse of AD occurring. We will conduct survivor analysis of results.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01772056
|Departamento de Salud Valencia-La Ribera|
|Alzira, Valencia, Spain, 46600|
|Departamento de Salud Valencia - Hospital General|
|Valencia, Spain, 46014|
|Departamento de Salud Valencia-Arnau-Lliria|
|Valencia, Spain, 46015|
|Valencia, Spain, 46010|
|Principal Investigator:||Elena Rubio Gomis, PhD MD||Consorcio Hospital General Universitario de Valencia y Universidad de Valencia|