Clinical trial NCT01772056: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Dermatitis, Atopic
Keywords: Dermatitis, Atopic
Randomized Controlled Trial
Child
Fluticasone
Preventive therapy
Lead sponsor: University of Valencia
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
name: Fundacion Investigación Hospital General Universitario de Valencia
First posted: 2013-01-21
Enrollment: 54
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Relapse in Atopic Dermatitis (AD).
timeFrame: 16 weeks
Secondary outcomes:
measure: Time to relapse
timeFrame: 16 weeks
measure: Incidence of relapse
timeFrame: 16 weeks
measure: severity of the relapse
timeFrame: 16 weeks
measure: Adverse events and adverse effects
timeFrame: 22 weeks
measure: Therapeutic compliance
timeFrame: 18 weeks
Other outcomes:
Locations:
city: Alzira
country: Spain
facility: Departamento de Salud Valencia-La Ribera
state: Valencia
city: Valencia
country: Spain
facility: Departamento Valencia-Clinic-Malvarrosa
city: Valencia
country: Spain
facility: Departamento de Salud Valencia - Hospital General
city: Valencia
country: Spain
facility: Departamento de Salud Valencia-Arnau-Lliria
Study officials:
affiliation: Consorcio Hospital General Universitario de Valencia y Universidad de Valencia
name: Elena Rubio Gomis, PhD MD
role: PRINCIPAL_INVESTIGATOR
References: