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

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ClinicalTrials.gov Identifier: NCT01772056
Recruitment Status : Terminated (Patient recruitment is very slow, economic grant has ended and the number of patients is enough according to sample size (22 children/ arm).)
First Posted : January 21, 2013
Last Update Posted : January 9, 2015
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Dermatitis, Atopic Drug: Fluticasone, cream Drug: Placebo, Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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 Start Date : December 2009
Primary Completion Date : January 2012
Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
U.S. FDA Resources

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :
  1. 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).

Secondary Outcome Measures :
  1. 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.

  2. Incidence of relapse [ Time Frame: 16 weeks ]
    The proportion of children experiencing a relapse of AD during DMP.

  3. 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)

  4. Adverse events and adverse effects [ Time Frame: 22 weeks ]
    Safety was assessed by monitoring adverse events and adverse effects throughout the study.

  5. Therapeutic compliance [ Time Frame: 18 weeks ]
    To describe the therapeutic compliance by means of the control of the drug used.

Eligibility Criteria

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Ages Eligible for Study:   2 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01772056

Departamento de Salud Valencia-La Ribera
Alzira, Valencia, Spain, 46600
Departamento Valencia-Clinic-Malvarrosa
Valencia, Spain, 46010
Departamento de Salud Valencia - Hospital General
Valencia, Spain, 46014
Departamento de Salud Valencia-Arnau-Lliria
Valencia, Spain, 46015
Sponsors and Collaborators
Elena Rubio Gomis
Instituto de Salud Carlos III
Fundacion Investigación Hospital General Universitario de Valencia
Principal Investigator: Elena Rubio Gomis, PhD MD Consorcio Hospital General Universitario de Valencia y Universidad de Valencia
More Information

Responsible Party: Elena Rubio Gomis, Professor of Pharmacology. Clinical Pharmacology, University of Valencia
ClinicalTrials.gov Identifier: NCT01772056     History of Changes
Other Study ID Numbers: FLUTIDANENES08
EC08/00004 ( Other Grant/Funding Number: Instituto de Salud Carlos III (ISCIII). Spain )
2008-005360-14 ( EudraCT Number )
First Posted: January 21, 2013    Key Record Dates
Last Update Posted: January 9, 2015
Last Verified: January 2015

Keywords provided by Elena Rubio Gomis, University of Valencia:
Dermatitis, Atopic
Randomized Controlled Trial
Preventive therapy

Additional relevant MeSH terms:
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Immune System Diseases
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents