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

Dermatitis, Atopic Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01772056
• Other study ID #: FLUTIDANENES08
• Secondary ID: EC08/000042008-0
• Status: Terminated
• Phase: Phase 3
• First received: January 16, 2013
• Last updated: January 8, 2015
• Start date: December 2009
• Est. completion date: March 2013

Study information

• Verified date: January 2015
• Source: University of Valencia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 54
• Est. completion date: March 2013
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 10 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

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,
Control Group: on treatment with twice weekly on consecutive days vehicle cream for 16 weeks or at relapse.

Locations

Country	Name	City	State
Spain	Departamento de Salud Valencia-La Ribera	Alzira	Valencia
Spain	Departamento de Salud Valencia - Hospital General	Valencia
Spain	Departamento de Salud Valencia-Arnau-Lliria	Valencia
Spain	Departamento Valencia-Clinic-Malvarrosa	Valencia

Sponsors (3)

Lead Sponsor	Collaborator
Elena Rubio Gomis	Fundacion Investigación Hospital General Universitario de Valencia, Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relapse in Atopic Dermatitis (AD).	The primary study end point will be probability of a relapse of AD occurring (the relapse rate of AD).	16 weeks	No
Secondary	Time to relapse	The number of days from start of the Fluticasone propionate treatment in Double-blind Maintenance Phase (DMP) until AD relapse.	16 weeks	No
Secondary	Incidence of relapse	The proportion of children experiencing a relapse of AD during DMP.	16 weeks	No
Secondary	severity of the relapse	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)	16 weeks	No
Secondary	Adverse events and adverse effects	Safety was assessed by monitoring adverse events and adverse effects throughout the study.	22 weeks	Yes
Secondary	Therapeutic compliance	To describe the therapeutic compliance by means of the control of the drug used.	18 weeks	No