Back to resultsClinical Trial to Assess the Efficacy and Safety of Tacrolimus Ointment Treatment of Atopic Dermatitis in Adult Patients
Primary Purpose
Dermatitis, Atopic
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
tacrolimus ointment
Sponsored by
About this trial
This is an interventional treatment trial for Dermatitis, Atopic focused on measuring dermatitis, atopic, tacrolimus, adult
Eligibility Criteria
Inclusion Criteria:
- Male or female, any ethnic group, age ≥16
- Moderate to severe atopic dermatitis
- Has given informed consent
Exclusion Criteria:
- Erythroderma
- Pregnant or breast-feeding
- Skin infection on the affected area
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Physician's evaluation of clinical response
Patient's assessment of global response
Affected body surface area
Quality of Life at Baseline/Day 1 and Week 12/End of study
Changes of mEASI
Incidence of adverse events during the study, including all clinically significant laboratory values
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00523952
Brief Title
Clinical Trial to Assess the Efficacy and Safety of Tacrolimus Ointment Treatment of Atopic Dermatitis in Adult Patients
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
September 2005 (Actual)
Study Completion Date
September 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
Detailed Description
The study was a one arm non-comparative study. The only study medication was Tacrolimus ointment 0.1% (Protopic ® 0.1%).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis, Atopic
Keywords
dermatitis, atopic, tacrolimus, adult
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
303 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
tacrolimus ointment
Other Intervention Name(s)
Protopic, FK506 Ointment
Intervention Description
tacrolimus, single arm, 0.1 ointment
Primary Outcome Measure Information:
Title
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
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Physician's evaluation of clinical response
Time Frame
12 weeks
Title
Patient's assessment of global response
Time Frame
12 weeks
Title
Affected body surface area
Time Frame
12 weeks
Title
Quality of Life at Baseline/Day 1 and Week 12/End of study
Time Frame
12 weeks
Title
Changes of mEASI
Time Frame
12 weeks
Title
Incidence of adverse events during the study, including all clinically significant laboratory values
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female, any ethnic group, age ≥16
Moderate to severe atopic dermatitis
Has given informed consent
Exclusion Criteria:
Erythroderma
Pregnant or breast-feeding
Skin infection on the affected area
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Central Contact
Organizational Affiliation
Astellas Pharma GmbH
Official's Role
Study Director
Facility Information:
City
Brno
Country
Czech Republic
City
Hradec Kralove
Country
Czech Republic
City
Ostrava
Country
Czech Republic
City
Plzen
Country
Czech Republic
City
Prague
Country
Czech Republic
City
Tabor
Country
Czech Republic
City
Usti nad Labem
Country
Czech Republic
City
Budapest
Country
Hungary
City
Debrecen
Country
Hungary
City
Györ
Country
Hungary
City
Kecskemet
Country
Hungary
City
Miskolc
Country
Hungary
City
Pecs
Country
Hungary
City
Bialystok
Country
Poland
City
Czestochowa
Country
Poland
City
Gdansk
Country
Poland
City
Katowice
Country
Poland
City
Krakow
Country
Poland
City
Lodz
Country
Poland
City
Lublin
Country
Poland
City
Poznan
Country
Poland
City
Sopot
Country
Poland
City
Szczecin
Country
Poland
City
Warsaw
Country
Poland
City
Wroclaw
Country
Poland
12. IPD Sharing Statement
Links:
URL
http://www.clinicaltrials.jp/user/ctrSearch_e.jsp
Description
Link to Results on JAPIC - enter 140565 in the JapicCTI-RNo. field
Learn more about this trial
Clinical Trial to Assess the Efficacy and Safety of Tacrolimus Ointment Treatment of Atopic Dermatitis in Adult Patients
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