Dermatitis, Atopic
Conditions
Keywords
Dermatitis, atopic, Tacrolimus, Child, treatment outcomes
Brief summary
A long-term 0.03% tacrolimus ointment based regimen comprising of up to 6 weeks of initial twice daily treatment and subsequent twice weekly prophylactic application can effectively treat active lesions of atopic dermatitis, and prevent, delay, and reduce flares.
Interventions
DRUGtacrolimus ointment
Topical application
DRUGPlacebo ointment
Topical application
Sponsors
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
* Male or female patient of any ethnic group * Patient was at least 2-15 years old and suffered from mild to severe atopic dermatitis (Rajka/Langeland score of at least 3)
Exclusion criteria
* Patient had a genetic epidermal barrier defect such as Netherton's syndrome or generalised erythroderma * Patient had a clinically significant skin infection on the affected (and to be treated) area
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of exacerbations of atopic dermatitis requiring intervention. | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Time to first exacerbation requiring intervention; exacerbation treatment days, periods and time to first exacerbation; physician and patient assessment of affected area, treatment response; quality of life; global response. | 12 months |
Countries
Belgium, Czechia, Finland, France, Germany, Hungary, Italy, Netherlands, Portugal, Spain, United Kingdom
Outcome results
None listed