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
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.
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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 |
Lead Sponsor | Collaborator |
---|---|
Elena Rubio Gomis | Fundacion Investigación Hospital General Universitario de Valencia, Instituto de Salud Carlos III |
Spain,
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 |
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