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

Phase 3

Terminated

• Conditions: Dermatitis, Atopic
• Interventions: Drug: Fluticasone, cream; Drug: Placebo,

• Registration Number: NCT01772056
• Lead Sponsor: Elena Rubio Gomis

Brief 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.

Study Timeline

• Study Start: 2009-12
• Primary Completion: 2012-01
• Study First Submitted: 2013-01-16
• Study First Submitted QC: 2013-01-18
• Study First Posted: 2013-01-21
• Study Completion: 2013-03
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-08
• Last Update Posted: 2015-01-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• Children, aged 2 to 10 years, with mild or moderate acute flare of AD (SCORAD up to 50) and no treatment for this episode of AD.
• written informed consent to patients' parents.

Exclusion Criteria

• >30% of affected body surface area AD.
• Head affected.
• Fluticasone o vehicle allergy.
• Patients with any medical condition for which topical corticosteroids were contraindicated
• Patients with other dermatological conditions that may have prevented accurate assessment of AD
• Patients with receiving any concomitant medications that might have affected the study's outcome.
• Other medical history that could interfere with the evaluation of study treatment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluticasone, cream	Fluticasone, cream	fluticasone propionate (FP) cream of 0.05%. The vehicle is:Base PFCO/W, Propyleneglycol and Water conservant.
Placebo, cream	Placebo,	Vehicle cream is composed by Base PFCO/W, Propyleneglycol and Water conservant.

Primary Outcome Measures

Name	Time	Method
Relapse in Atopic Dermatitis (AD).	16 weeks	The primary study end point will be probability of a relapse of AD occurring (the relapse rate of AD).

Secondary Outcome Measures

Name	Time	Method
Time to relapse	16 weeks	The number of days from start of the Fluticasone propionate treatment in Double-blind Maintenance Phase (DMP) until AD relapse.
Incidence of relapse	16 weeks	The proportion of children experiencing a relapse of AD during DMP.
severity of the relapse	16 weeks	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	22 weeks	Safety was assessed by monitoring adverse events and adverse effects throughout the study.
Therapeutic compliance	18 weeks	To describe the therapeutic compliance by means of the control of the drug used.

Trial Locations

Locations (4)

Departamento Valencia-Clinic-Malvarrosa; 🇪🇸 Valencia, Spain

Departamento de Salud Valencia-La Ribera; 🇪🇸 Alzira, Valencia, Spain

Departamento de Salud Valencia - Hospital General; 🇪🇸 Valencia, Spain

Departamento de Salud Valencia-Arnau-Lliria; 🇪🇸 Valencia, Spain