Moderate/Severe Atopic Dermatitis Clinical Trial
Official title:
Proactive Treatment With Tacrolimus Ointment in Children With Moderate/Severe Atopic Dermatitis: A Randomized, Multicenter, Open-label Study
To assess if proactive, 2 times-weekly application of tacrolimus ointment can extend remission time to relapse and reduce the incidence of disease exacerbation (DE) in paediatric patients over a period of 6 months.
This study includes three periods. First a screening period of up to one week. Second an open-label treatment period of up to six weeks where all participants apply tacrolimus ointment. Third an open-label disease control period of up to six months where half of the participants apply tacrolimus ointment and the other half of the participants do not apply treatment. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment