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

Last updated: January 8, 2015
Sponsor: Elena Rubio Gomis
Overall Status: Terminated

Phase

3

Condition

Allergy

Eczema (Atopic Dermatitis - Pediatric)

Atopic Dermatitis

Treatment

N/A

Clinical Study ID

NCT01772056
FLUTIDANENES08
EC08/00004
2008-005360-14
  • Ages 2-10
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Children, aged 2 to 10 years, with mild or moderate acute flare of AD (SCORAD up to
  1. and no treatment for this episode of AD.
  • written informed consent to patients' parents.

Exclusion

Exclusion Criteria:

  • >30% of affected body surface area AD.

  • Head affected.

  • Fluticasone o vehicle allergy.

  • Patients with any medical condition for which topical corticosteroids werecontraindicated

  • Patients with other dermatological conditions that may have prevented accurateassessment of AD

  • Patients with receiving any concomitant medications that might have affected thestudy's outcome.

  • Other medical history that could interfere with the evaluation of study treatment.

Study Design

Total Participants: 54
Study Start date:
December 01, 2009
Estimated Completion Date:
March 31, 2013

Study 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.

Connect with a study center

  • Departamento de Salud Valencia-La Ribera

    Alzira, Valencia 46600
    Spain

    Site Not Available

  • Departamento Valencia-Clinic-Malvarrosa

    Valencia, 46010
    Spain

    Site Not Available

  • Departamento de Salud Valencia - Hospital General

    Valencia, 46014
    Spain

    Site Not Available

  • Departamento de Salud Valencia-Arnau-Lliria

    Valencia, 46015
    Spain

    Site Not Available

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