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

Overview[ - collapse ][ - ]

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.
ConditionDermatitis, Atopic
InterventionDrug: Fluticasone, cream
Drug: Placebo,
PhasePhase 3
SponsorElena Rubio Gomis
Responsible PartyUniversity of Valencia
ClinicalTrials.gov IdentifierNCT01772056
First ReceivedJanuary 16, 2013
Last UpdatedJanuary 20, 2013
Last verifiedJanuary 2013

Tracking Information[ + expand ][ + ]

First Received DateJanuary 16, 2013
Last Updated DateJanuary 20, 2013
Start DateDecember 2009
Estimated Primary Completion DateMarch 2013
Current Primary Outcome MeasuresRelapse 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).
Current 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.

Descriptive Information[ + expand ][ + ]

Brief TitleEfficacy Study of Topical Twice Weekly Fluticasone Treatment to Reduce Relapse in Atopic Dermatitis in Children
Official TitleRandomised 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
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.
Study TypeInterventional
Study PhasePhase 3
Study DesignAllocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
ConditionDermatitis, Atopic
InterventionDrug: Fluticasone, cream
Experimental Group: on treatment with twice weekly on consecutive days FP cream of 0.05% for 16 weeks or at relapse
Drug: Placebo,
Control Group: on treatment with twice weekly on consecutive days vehicle cream for 16 weeks or at relapse.
Study Arm (s)
  • Experimental: Fluticasone, cream
    fluticasone propionate (FP) cream of 0.05%. The vehicle is:Base PFCO/W, Propyleneglycol and Water conservant.
  • Placebo Comparator: Placebo, cream
    Vehicle cream is composed by Base PFCO/W, Propyleneglycol and Water conservant.

Recruitment Information[ + expand ][ + ]

Recruitment StatusRecruiting
Estimated Enrollment100
Estimated Completion DateMarch 2013
Estimated Primary Completion DateJanuary 2012
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.
GenderBoth
Ages2 Years
Accepts Healthy VolunteersNo
ContactsContact: Alejandro Bernalte, Pharmacist
34961972000
bernalte_ale@gva.es
Location CountriesSpain

Administrative Information[ + expand ][ + ]

NCT Number NCT01772056
Other Study ID NumbersFLUTIDANENES08
Has Data Monitoring CommitteeNo
Information Provided ByUniversity of Valencia
Study SponsorElena Rubio Gomis
CollaboratorsInstituto 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
Verification DateJanuary 2013

Locations[ + expand ][ + ]

Departamento de Salud Valencia-La Ribera
Alzira, Valencia, Spain, 46600
Contact: Vicente Palop Larrea, PhD MD | 962458190 | vpalop@hospital-ribera.com
Sub-Investigator: Vicente Palop Larrea, PhD MD
Recruiting
Departamento de Salud Valencia - Hospital General
Valencia, Spain, 46014
Contact: Bernalte | bernalte_ale@gva.es
Sub-Investigator: Antonio Martorell Aragones, PhD MD
Recruiting
Departamento de Salud Valencia-Arnau-Lliria
Valencia, Spain, 46015
Contact: Laura Aranda Grau, PhD MD | 34962761208 | laura_arandagrau@yahoo.es
Sub-Investigator: Antonio M Abella Bazataqui, PhD MD
Recruiting
Departamento Valencia-Clinic-Malvarrosa
Valencia, Spain, 46010
Contact: Rosario Carpi Lobaton, MD | 34961851461 | paalcri@hotmail.com
Sub-Investigator: Rosario Carpi Lobaton, MD
Recruiting