NCT01772056

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2009

Typical duration for phase_3

Geographic Reach
1 country

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 16, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 21, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

January 9, 2015

Status Verified

January 1, 2015

Enrollment Period

2.1 years

First QC Date

January 16, 2013

Last Update Submit

January 8, 2015

Conditions

Dermatitis, Atopic

Keywords

Dermatitis, AtopicRandomized Controlled TrialChildFluticasonePreventive therapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Time to relapse

    16 weeks

  • Incidence of relapse

    16 weeks

  • severity of the relapse

    16 weeks

  • Adverse events and adverse effects

    22 weeks

  • Therapeutic compliance

    18 weeks

Study Arms (2)

Fluticasone, cream

EXPERIMENTAL

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

Drug: Fluticasone, cream

Placebo, cream

PLACEBO COMPARATOR

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

Drug: Placebo,

Interventions

Fluticasone, creamDRUG

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

Fluticasone, cream
Placebo,DRUG

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

Placebo, cream

Eligibility Criteria

Age2 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • \>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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Departamento de Salud Valencia-La Ribera

Alzira, Valencia, 46600, Spain

Location

Departamento Valencia-Clinic-Malvarrosa

Valencia, Valencia, 46010, Spain

Location

Departamento de Salud Valencia - Hospital General

Valencia, Valencia, 46014, Spain

Location

Departamento de Salud Valencia-Arnau-Lliria

Valencia, Valencia, 46015, Spain

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Fluticasone

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

AndrostadienesAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Elena Rubio Gomis, PhD MD

    Consorcio Hospital General Universitario de Valencia y Universidad de Valencia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Pharmacology. Clinical Pharmacology

Study Record Dates

First Submitted

January 16, 2013

First Posted

January 21, 2013

Study Start

December 1, 2009

Primary Completion

January 1, 2012

Study Completion

March 1, 2013

Last Updated

January 9, 2015

Record last verified: 2015-01

Locations

ES(4)