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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University of Valencia
Sponsor:
Collaborators:
Instituto de Salud Carlos III
Fundación para la Investigación del Hospital Clínico de Valencia
Information provided by (Responsible Party):
Elena Rubio Gomis, University of Valencia
ClinicalTrials.gov Identifier:
NCT01772056
First received: January 16, 2013
Last updated: January 20, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Dermatitis, Atopic
Drug: Fluticasone, cream
Drug: Placebo,
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by University of Valencia:

Primary Outcome Measures:
  • Relapse in Atopic Dermatitis (AD). [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    The number of days from start of the Fluticasone propionate treatment in Double-blind Maintenance Phase (DMP) until AD relapse.

  • Incidence of relapse [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    The proportion of children experiencing a relapse of AD during DMP.

  • severity of the relapse [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 22 weeks ] [ Designated as safety issue: Yes ]
    Safety was assessed by monitoring adverse events and adverse effects throughout the study.

  • Therapeutic compliance [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
    To describe the therapeutic compliance by means of the control of the drug used.


Estimated Enrollment: 100
Study Start Date: December 2009
Estimated Study Completion Date: March 2013
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   2 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01772056

Contacts
Contact: Alejandro Bernalte, Pharmacist 34961972000 ext 52185 bernalte_ale@gva.es
Contact: Arancha Macia 34962458190 macia.arancha@experior.es

Locations
Spain
Departamento de Salud Valencia-La Ribera Recruiting
Alzira, Valencia, Spain, 46600
Contact: Vicente Palop Larrea, PhD MD    962458190    vpalop@hospital-ribera.com   
Sub-Investigator: Vicente Palop Larrea, PhD MD         
Sub-Investigator: Juan C Julia Benito, PhD MD         
Departamento de Salud Valencia - Hospital General Recruiting
Valencia, Spain, 46014
Contact: Bernalte       bernalte_ale@gva.es   
Sub-Investigator: Antonio Martorell Aragones, PhD MD         
Sub-Investigator: Juan C Cerda Mir, MD         
Sub-Investigator: Inocencia Martinez Mir, PhD MD         
Sub-Investigator: Alejandro Bernalte Sese, Pharmacist         
Sub-Investigator: Mª Isabel Febrer Bosch, PhD MD         
Sub-Investigator: Francisco J Morales Olivas, PhD MD         
Sub-Investigator: Cristina Morales Carpi, PhD MD         
Sub-Investigator: Ana B Ferrer Bautista, MD         
Sub-Investigator: Mª Esther Apolinar Valiente, MD         
Sub-Investigator: Mª Antonia Beltran Marques, MD         
Sub-Investigator: Sandra Solaz Barrios, PhD MD         
Sub-Investigator: Mª Victoria Planelles Cantarino, MD         
Sub-Investigator: Pedro Polo Marti, PhD MD         
Sub-Investigator: Victoria E Garcia Martinez, MD         
Sub-Investigator: Dolores Marmaneu Laguia, MD         
Sub-Investigator: Mª Mercedes Loriente Tur, MD         
Sub-Investigator: Olga Peñalver Giner, MD         
Sub-Investigator: Mª Begoña Rodriguez Gracia, MD         
Sub-Investigator: Mª Jose Tejedor Sanz, MD         
Sub-Investigator: Mª Enriqueta Burches Greus, PhD MD         
Sub-Investigator: Mª Carmen Tordera Marti, MD         
Sub-Investigator: Teresa Margarit Vercher, MD         
Sub-Investigator: Inmaculada Llosa Cortes, MD         
Sub-Investigator: Trinidad Alvarez de Laviada Mulero, PhD MD         
Sub-Investigator: Emilio J Ferriols Gil, PhD MD         
Sub-Investigator: Ruben R Felix Toledo, MD         
Sub-Investigator: Natividad Pons Fernandez, MD         
Principal Investigator: Elena Rubio Gomis, PhD MD         
Departamento de Salud Valencia-Arnau-Lliria Recruiting
Valencia, Spain, 46015
Contact: Laura Aranda Grau, PhD MD    34962761208    laura_arandagrau@yahoo.es   
Contact: Irene Alvarez Gonzalez, MD    34962761208    irenmed@yahoo.es   
Sub-Investigator: Antonio M Abella Bazataqui, PhD MD         
Sub-Investigator: Irene Alvarez Gonzalez, MD         
Sub-Investigator: Laura Aranda Grau, PhD MD         
Departamento Valencia-Clinic-Malvarrosa Recruiting
Valencia, Spain, 46010
Contact: Rosario Carpi Lobaton, MD    34961851461    paalcri@hotmail.com   
Sub-Investigator: Rosario Carpi Lobaton, MD         
Sub-Investigator: Francisco J Fernandez Ros, MD         
Sponsors and Collaborators
Elena Rubio Gomis
Instituto de Salud Carlos III
Fundación para la Investigación del Hospital Clínico de Valencia
Investigators
Principal Investigator: Elena Rubio Gomis, PhD MD Consorcio Hospital General Universitario de Valencia y Universidad de Valencia
  More Information

No publications provided

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, 2008-005360-14
Study First Received: January 16, 2013
Last Updated: January 20, 2013
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by University of Valencia:
Dermatitis, Atopic
Randomized Controlled Trial
Child
Fluticasone
Preventive therapy

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

ClinicalTrials.gov processed this record on August 21, 2014