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

Study Overview
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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.

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.

Official Title
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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

Conditions
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Dermatitis, Atopic

Intervention / Treatment
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* Drug: Fluticasone, cream
* Drug: Placebo,


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fluticasone, cream<br>fluticasone propionate (FP) cream of 0.05%. The vehicle is:Base PFCO/W, Propyleneglycol and Water conservant. | Drug: Fluticasone, cream<br>* Experimental Group: on treatment with twice weekly on consecutive days FP cream of 0.05% for 16 weeks or at relapse<br>|
| Placebo Comparator: Placebo, cream<br>Vehicle cream is composed by Base PFCO/W, Propyleneglycol and Water conservant. | Drug: Placebo,<br>* Control Group: on treatment with twice weekly on consecutive days vehicle cream for 16 weeks or at relapse.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse in Atopic Dermatitis (AD). | The primary study end point will be probability of a relapse of AD occurring (the relapse rate of AD). | 16 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dermatitis, Atopic, Randomized Controlled Trial, Child, Fluticasone, Preventive therapy