NCT01772056

Efficacy Study of Topical Twice Weekly Fluticasone Treatment to Reduce Relapse in Atopic Dermatitis in Children

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Elena Rubio Gomis · Academic / Other
• Sex: All
• Age: 2 Years – 10 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Dermatitis, Atopic

Interventions

Type	Name	Description
DRUG	Fluticasone, cream	Experimental Group: on treatment with twice weekly on consecutive days FP cream of 0.05% for 16 weeks or at relapse
DRUG	Placebo,	Control Group: on treatment with twice weekly on consecutive days vehicle cream for 16 weeks or at relapse.

Timeline

• Start date: 2009-12-01
• Primary completion: 2012-01-01
• Completion: 2013-03-01
• First posted: 2013-01-21
• Last updated: 2015-01-09

Locations

4 sites across 1 country: Spain