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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2013-03-31

Brief Summary

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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.

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Detailed Description

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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

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Dermatitis, Atopic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Fluticasone, cream

fluticasone propionate (FP) cream of 0.05%. The vehicle is:Base PFCO/W, Propyleneglycol and Water conservant.

Group Type EXPERIMENTAL

Fluticasone, cream

Intervention Type DRUG

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

Placebo, cream

Vehicle cream is composed by Base PFCO/W, Propyleneglycol and Water conservant.

Group Type PLACEBO_COMPARATOR

Placebo,

Intervention Type DRUG

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

Interventions

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Fluticasone, cream

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

Intervention Type DRUG

Placebo,

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

2 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No