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

Phase 3TerminatedNCT01772056

Elena Rubio Gomis54 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Dermatitis, Atopic

Interventions

Fluticasone, creamDRUG

Experimental Group: on treatment with twice weekly on consecutive days FP cream of 0.05% for 16 weeks or at relapse

Placebo,DRUG

Control Group: on treatment with twice weekly on consecutive days vehicle cream for 16 weeks or at relapse.

Eligibility

Sex: ALLMin age: 2 YearsMax age: 10 Years

Medical Language ↔ Plain English

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.

Locations (4)

Departamento de Salud Valencia-La Ribera

Alzira, Valencia, Spain

Departamento Valencia-Clinic-Malvarrosa

Valencia, Valencia, Spain

Departamento de Salud Valencia - Hospital General

Valencia, Valencia, Spain

Departamento de Salud Valencia-Arnau-Lliria

Valencia, Valencia, Spain

Outcomes

Primary Outcomes

Relapse in Atopic Dermatitis (AD).

The primary study end point will be probability of a relapse of AD occurring (the relapse rate of AD).

Time frame: 16 weeks

Secondary Outcomes

Time to relapse

The number of days from start of the Fluticasone propionate treatment in Double-blind Maintenance Phase (DMP) until AD relapse.

Time frame: 16 weeks

Incidence of relapse

The proportion of children experiencing a relapse of AD during DMP.

Time frame: 16 weeks

severity of the relapse

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)

Time frame: 16 weeks

Adverse events and adverse effects

Safety was assessed by monitoring adverse events and adverse effects throughout the study.

Time frame: 22 weeks

Therapeutic compliance

To describe the therapeutic compliance by means of the control of the drug used.

Time frame: 18 weeks

Data from ClinicalTrials.gov

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