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
Overview
- Phase
- Phase 3
- Intervention
- Fluticasone, cream
- Conditions
- Dermatitis, Atopic
- Sponsor
- Elena Rubio Gomis
- Enrollment
- 54
- Locations
- 4
- Primary Endpoint
- Relapse in Atopic Dermatitis (AD).
- Status
- Terminated
- Last Updated
- 11 years ago
Overview
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.
Investigators
Elena Rubio Gomis
Professor of Pharmacology. Clinical Pharmacology
University of Valencia
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.
Arms & Interventions
Fluticasone, cream
fluticasone propionate (FP) cream of 0.05%. The vehicle is:Base PFCO/W, Propyleneglycol and Water conservant.
Intervention: Fluticasone, cream
Placebo, cream
Vehicle cream is composed by Base PFCO/W, Propyleneglycol and Water conservant.
Intervention: Placebo,
Outcomes
Primary Outcomes
Relapse in Atopic Dermatitis (AD).
Time Frame: 16 weeks
The primary study end point will be probability of a relapse of AD occurring (the relapse rate of AD).
Secondary Outcomes
- Time to relapse(16 weeks)
- Incidence of relapse(16 weeks)
- severity of the relapse(16 weeks)
- Adverse events and adverse effects(22 weeks)
- Therapeutic compliance(18 weeks)