Moderate/Severe Atopic Dermatitis
Conditions
Keywords
tacrolimus, Protopic, pediatric, atopic dermatitis, China
Brief summary
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.
Detailed description
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.
Interventions
DRUGtacrolimus
Sponsors
Astellas Pharma China, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosed as AD according to Williams diagnostic criteria. 2. Moderate or severe atopic dermatitis according to the criteria of Rajka and Langeland 3. At least approximately 10 % of body area 4. Patient is able to reach the centre within 3 days in case of a disease exacerbation. 5. Patient's legal representative(s) has/have given written informed consent. If the patient is capable of understanding the purposes and risks of the trial, written informed consent has been obtained from the patient as well
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to first DE (disease exacerbation) | 6 months of DCP(Disease Control Period) after 2 to 6 weeks of OLP(Open Label Period) |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events | 6 months of DCP (Disease Control Period) after 2 to 6 weeks of OLP (Open Label Period) |
| Number of DEs during the DCP | 6 months of DCP (Disease Control Period) |
| Eczema Area and Severity Index (EASI) | 6 months of DCP (Disease Control Period) after 2 to 6 weeks of OLP (Open Label Period) |
| Quantity of tacrolimus ointment used | 6 months of DCP (Disease Control Period) after 2 to 6 weeks of OLP (Open Label Period) |
| Duration of DE during DCP | 6 months of DCP (Disease Control Period) |
| The overall efficacy during OLP | After 2 to 6 weeks of OLP (Open Label Period) |
| Investigator's Global Assessment (IGA) | 6 months of DCP (Disease Control Period) after 2 to 6 weeks of OLP (Open Label Period) |
Countries
China
Outcome results
None listed