Treatment and Control of Atopic Dermatitis With 0.03% Tacrolimus Ointment
Phase 3
Completed
- Conditions
- Dermatitis, Atopic
- Interventions
- Drug: Placebo ointment
- Registration Number
- NCT00480896
- Lead Sponsor
- Astellas Pharma Inc
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 250
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Placebo ointment - 1 tacrolimus ointment -
- Primary Outcome Measures
Name Time Method Number of exacerbations of atopic dermatitis requiring intervention. 12 months
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
3 Sites
🇨🇿Praha, Czech Republic