Dermatitis, Atopic
Conditions
Keywords
Dermatitis, Atopic, Randomized Controlled Trial, Child, Fluticasone, Preventive therapy
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.
Interventions
DRUGFluticasone, cream
Experimental Group: on treatment with twice weekly on consecutive days FP cream of 0.05% for 16 weeks or at relapse
DRUGPlacebo,
Control Group: on treatment with twice weekly on consecutive days vehicle cream for 16 weeks or at relapse.
Sponsors
Instituto de Salud Carlos III
Fundacion Investigación Hospital General Universitario de Valencia
Elena Rubio Gomis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Years to 10 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relapse in Atopic Dermatitis (AD). | 16 weeks | The primary study end point will be probability of a relapse of AD occurring (the relapse rate of AD). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to relapse | 16 weeks | The number of days from start of the Fluticasone propionate treatment in Double-blind Maintenance Phase (DMP) until AD relapse. |
| Incidence of relapse | 16 weeks | The proportion of children experiencing a relapse of AD during DMP. |
| severity of the relapse | 16 weeks | 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 | 22 weeks | Safety was assessed by monitoring adverse events and adverse effects throughout the study. |
| Therapeutic compliance | 18 weeks | To describe the therapeutic compliance by means of the control of the drug used. |
Countries
Spain
Outcome results
None listed