Dermatitis, Atopic Clinical Trial
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
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.
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. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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