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

January 8, 2015 updated by: Elena Rubio Gomis

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valencia, Spain, 46010
        • Departamento Valencia-Clinic-Malvarrosa
      • Valencia, Spain, 46014
        • Departamento de Salud Valencia - Hospital General
      • Valencia, Spain, 46015
        • Departamento de Salud Valencia-Arnau-Lliria
    • Valencia
      • Alzira, Valencia, Spain, 46600
        • Departamento de Salud Valencia-La Ribera

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relapse in Atopic Dermatitis (AD).
Time Frame: 16 weeks
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
Time Frame: 16 weeks
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
Time Frame: 16 weeks
The proportion of children experiencing a relapse of AD during DMP.
16 weeks
severity of the relapse
Time Frame: 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)
16 weeks
Adverse events and adverse effects
Time Frame: 22 weeks
Safety was assessed by monitoring adverse events and adverse effects throughout the study.
22 weeks
Therapeutic compliance
Time Frame: 18 weeks
To describe the therapeutic compliance by means of the control of the drug used.
18 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elena Rubio Gomis

Collaborators

Instituto de Salud Carlos III
Fundacion Investigación Hospital General Universitario de Valencia

Investigators

  • Principal Investigator: Elena Rubio Gomis, PhD MD, Consorcio Hospital General Universitario de Valencia y Universidad de Valencia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

January 16, 2013

First Submitted That Met QC Criteria

January 18, 2013

First Posted (Estimate)

January 21, 2013

Study Record Updates

Last Update Posted (Estimate)

January 9, 2015

Last Update Submitted That Met QC Criteria

January 8, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FLUTIDANENES08
  • EC08/00004 (Other Grant/Funding Number: Instituto de Salud Carlos III (ISCIII). Spain)
  • 2008-005360-14 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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