Efficacy Study of Topical Twice Weekly Fluticasone Treatment to Reduce Relapse in Atopic Dermatitis in Children
|ClinicalTrials.gov Identifier: NCT01772056|
Recruitment Status : Terminated (Patient recruitment is very slow, economic grant has ended and the number of patients is enough according to sample size (22 children/ arm).)
First Posted : January 21, 2013
Last Update Posted : January 9, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Dermatitis, Atopic||Drug: Fluticasone, cream Drug: Placebo,||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||54 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Study Start Date :||December 2009|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||March 2013|
Experimental: Fluticasone, cream
fluticasone propionate (FP) cream of 0.05%. The vehicle is:Base PFCO/W, Propyleneglycol and Water conservant.
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 Comparator: Placebo, cream
Vehicle cream is composed by Base PFCO/W, Propyleneglycol and Water conservant.
Control Group: on treatment with twice weekly on consecutive days vehicle cream for 16 weeks or at relapse.
- 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).
- Time to relapse [ Time Frame: 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 [ Time Frame: 16 weeks ]The proportion of children experiencing a relapse of AD during DMP.
- severity of the relapse [ Time Frame: 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 [ Time Frame: 22 weeks ]Safety was assessed by monitoring adverse events and adverse effects throughout the study.
- Therapeutic compliance [ Time Frame: 18 weeks ]To describe the therapeutic compliance by means of the control of the drug used.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01772056
|Departamento de Salud Valencia-La Ribera|
|Alzira, Valencia, Spain, 46600|
|Valencia, Spain, 46010|
|Departamento de Salud Valencia - Hospital General|
|Valencia, Spain, 46014|
|Departamento de Salud Valencia-Arnau-Lliria|
|Valencia, Spain, 46015|
|Principal Investigator:||Elena Rubio Gomis, PhD MD||Consorcio Hospital General Universitario de Valencia y Universidad de Valencia|