A Randomized, Open-label, Comparative Study to Evaluate an Intermittent Dosing Regimen of Fluticasone Propionate 0.05% Cream (Twice Per Week) in Reducing the Risk of Relapse When Added to Regular Daily Moisturization Using PHYSIOGEL Lotion in Paediatric Subjects With Stabilized Atopic Dermatitis

PHASE4CompletedINTERVENTIONAL
Enrollment

107

Participants

Timeline

Start Date

December 23, 2013

Primary Completion Date

February 15, 2015

Study Completion Date

February 15, 2015

Conditions
Skin Diseases
Interventions
DRUG

Fluticasone propionate

All subjects receive FP 0.05% cream twice daily up to 4 weeks to all affected sites and any newly occurring sites in ACUTE phase. After randomization in MAINTENANCE phase, subjects either receive emollient (Physiogel) twice daily extendedly plus FP 0.05% cream once daily twice a week to all healed sites and any newly occurring sites (Group A), or emollient (Physiogel) twice daily extendedly (Group B), up to 20 weeks. In FOLLOW-UP phase, all subjects apply emollient (Physiogel) twice daily up to 12 weeks.

Trial Locations (4)

200092

GSK Investigational Site, Shanghai

410007

GSK Investigational Site, Changsha

518038

GSK Investigational Site, Shenzhen

Unknown

GSK Investigational Site, Beijing

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT01915914 - A Randomized, Open-label, Comparative Study to Evaluate an Intermittent Dosing Regimen of Fluticasone Propionate 0.05% Cream (Twice Per Week) in Reducing the Risk of Relapse When Added to Regular Daily Moisturization Using PHYSIOGEL Lotion in Paediatric Subjects With Stabilized Atopic Dermatitis | Biotech Hunter | Biotech Hunter