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

Primary Purpose

Dermatitis, Atopic

Status
Terminated
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Fluticasone, cream
Placebo,
Sponsored by
Elena Rubio Gomis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dermatitis, Atopic focused on measuring Dermatitis, Atopic, Randomized Controlled Trial, Child, Fluticasone, Preventive therapy

Eligibility Criteria

2 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Departamento de Salud Valencia-La Ribera
  • Departamento Valencia-Clinic-Malvarrosa
  • Departamento de Salud Valencia - Hospital General
  • Departamento de Salud Valencia-Arnau-Lliria

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Fluticasone, cream

Placebo, cream

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 16, 2013
Last Updated
January 8, 2015
Sponsor
Elena Rubio Gomis
Collaborators
Instituto de Salud Carlos III, Fundacion Investigación Hospital General Universitario de Valencia
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1. Study Identification

Unique Protocol Identification Number
NCT01772056
Brief Title
Efficacy Study of Topical Twice Weekly Fluticasone Treatment to Reduce Relapse in Atopic Dermatitis in Children
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Terminated
Why Stopped
Patient recruitment is very slow, economic grant has ended and the number of patients is enough according to sample size (22 children/ arm).
Study Start Date
December 2009 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Elena Rubio Gomis
Collaborators
Instituto de Salud Carlos III, Fundacion Investigación Hospital General Universitario de Valencia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis, Atopic
Keywords
Dermatitis, Atopic, Randomized Controlled Trial, Child, Fluticasone, Preventive therapy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fluticasone, cream
Arm Type
Experimental
Arm Description
fluticasone propionate (FP) cream of 0.05%. The vehicle is:Base PFCO/W, Propyleneglycol and Water conservant.
Arm Title
Placebo, cream
Arm Type
Placebo Comparator
Arm Description
Vehicle cream is composed by Base PFCO/W, Propyleneglycol and Water conservant.
Intervention Type
Drug
Intervention Name(s)
Fluticasone, cream
Intervention Description
Experimental Group: on treatment with twice weekly on consecutive days FP cream of 0.05% for 16 weeks or at relapse
Intervention Type
Drug
Intervention Name(s)
Placebo,
Intervention Description
Control Group: on treatment with twice weekly on consecutive days vehicle cream for 16 weeks or at relapse.
Primary Outcome Measure Information:
Title
Relapse in Atopic Dermatitis (AD).
Description
The primary study end point will be probability of a relapse of AD occurring (the relapse rate of AD).
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Time to relapse
Description
The number of days from start of the Fluticasone propionate treatment in Double-blind Maintenance Phase (DMP) until AD relapse.
Time Frame
16 weeks
Title
Incidence of relapse
Description
The proportion of children experiencing a relapse of AD during DMP.
Time Frame
16 weeks
Title
severity of the relapse
Description
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
Title
Adverse events and adverse effects
Description
Safety was assessed by monitoring adverse events and adverse effects throughout the study.
Time Frame
22 weeks
Title
Therapeutic compliance
Description
To describe the therapeutic compliance by means of the control of the drug used.
Time Frame
18 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elena Rubio Gomis, PhD MD
Organizational Affiliation
Consorcio Hospital General Universitario de Valencia y Universidad de Valencia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Departamento de Salud Valencia-La Ribera
City
Alzira
State/Province
Valencia
ZIP/Postal Code
46600
Country
Spain
Facility Name
Departamento Valencia-Clinic-Malvarrosa
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Departamento de Salud Valencia - Hospital General
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Departamento de Salud Valencia-Arnau-Lliria
City
Valencia
ZIP/Postal Code
46015
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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