Treatment and Control of Atopic Dermatitis With 0.03% Tacrolimus Ointment

Phase 3

Completed

• Conditions: Dermatitis, Atopic
• Interventions: Drug: Placebo ointment; Drug: tacrolimus 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

Study Timeline

• Study Start: 2004-06
• Primary Completion: 2005-11
• Study Completion: 2005-11
• Study First Submitted: 2007-05-30
• Study First Submitted QC: 2007-05-30
• Study First Posted: 2007-05-31
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-17
• Last Update Posted: 2014-09-18

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