Clinical Trial to Assess the Efficacy and Safety of Tacrolimus Ointment Treatment of Atopic Dermatitis in Adult Patients
A 12-week, Exploratory, Non-comparative, Multi-centre Study to Evaluate the Efficacy and Safety of 0.1% Tacrolimus Ointment Administered in Adults With Moderate to Severe Atopic Dermatitis
1 other identifier
interventional
303
3 countries
25
Brief Summary
Objective: Assess efficacy and safety of tacrolimus ointment when used in adults with moderate or severe atopic dermatitis. The ointment was applied on the affected skin twice daily for 3 weeks and then once daily until all lesions were cleared
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2004
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 31, 2007
CompletedFirst Posted
Study publicly available on registry
September 3, 2007
CompletedSeptember 1, 2014
August 1, 2014
1.7 years
August 31, 2007
August 28, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of patients with at least 50% (i.e. at least moderate) improvement according to the Physician's global evaluation of clinical response between Baseline and the Week 12/End of Study Visit
12 weeks
Secondary Outcomes (6)
Physician's evaluation of clinical response
12 weeks
Patient's assessment of global response
12 weeks
Affected body surface area
12 weeks
Quality of Life at Baseline/Day 1 and Week 12/End of study
12 weeks
Changes of mEASI
12 weeks
- +1 more secondary outcomes
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Male or female, any ethnic group, age ≥16
- Moderate to severe atopic dermatitis
- Has given informed consent
You may not qualify if:
- Erythroderma
- Pregnant or breast-feeding
- Skin infection on the affected area
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Unknown Facility
Brno, Czechia
Unknown Facility
Hradec Králové, Czechia
Unknown Facility
Ostrava, Czechia
Unknown Facility
Pilsen, Czechia
Unknown Facility
Prague, Czechia
Unknown Facility
Tábor, Czechia
Unknown Facility
Ústí nad Labem, Czechia
Unknown Facility
Budapest, Hungary
Unknown Facility
Debrecen, Hungary
Unknown Facility
Győr, Hungary
Unknown Facility
Kecskemét, Hungary
Unknown Facility
Miskolc, Hungary
Unknown Facility
Pécs, Hungary
Unknown Facility
Bialystok, Poland
Unknown Facility
Częstochowa, Poland
Unknown Facility
Gdansk, Poland
Unknown Facility
Katowice, Poland
Unknown Facility
Krakow, Poland
Unknown Facility
Lodz, Poland
Unknown Facility
Lublin, Poland
Unknown Facility
Poznan, Poland
Unknown Facility
Sopot, Poland
Unknown Facility
Szczecin, Poland
Unknown Facility
Warsaw, Poland
Unknown Facility
Wroclaw, Poland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Central Contact
Astellas Pharma GmbH
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2007
First Posted
September 3, 2007
Study Start
January 1, 2004
Primary Completion
September 1, 2005
Study Completion
September 1, 2005
Last Updated
September 1, 2014
Record last verified: 2014-08