Back to resultsTreatment and Control of Atopic Dermatitis With 0.1% Tacrolimus Ointment
Primary Purpose
Dermatitis, Atopic
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
tacrolimus ointment
Placebo ointment
Sponsored by
About this trial
This is an interventional treatment trial for Dermatitis, Atopic focused on measuring Dermatitis, atopic, Tacrolimus, Adult, treatment outcomes
Eligibility Criteria
Inclusion Criteria:
- Male or female patient of any ethnic group
- Patient was at least 16 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Number of exacerbations of atopic dermatitis requiring intervention.
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00480610
Brief Title
Treatment and Control of Atopic Dermatitis With 0.1% Tacrolimus Ointment
Official Title
Clinical Study on Tacrolimus Ointment Over the Long-term. "CONTROL Study - Adults"
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
November 2005 (Actual)
Study Completion Date
November 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
Long-term 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 & reduce flares
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, treatment outcomes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
226 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
tacrolimus ointment
Other Intervention Name(s)
Protopic®
Intervention Description
Topical application
Intervention Type
Drug
Intervention Name(s)
Placebo ointment
Intervention Description
Topical application
Primary Outcome Measure Information:
Title
Number of exacerbations of atopic dermatitis requiring intervention.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
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
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female patient of any ethnic group
Patient was at least 16 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Organizational Affiliation
Klinik und Poliklinik für Dermatologie und Allergologie, Ludwig-Maximilians Universität
Official's Role
Principal Investigator
Facility Information:
City
Innsbruck
Country
Austria
City
Bruxelles
Country
Belgium
City
Edegem
Country
Belgium
City
Praha
Country
Czech Republic
City
Aarjus
Country
Denmark
City
Helsinki
Country
Finland
City
Paris
Country
France
City
St Etienne
Country
France
City
Bonn
Country
Germany
City
Dresden
Country
Germany
City
Duesseldorf
Country
Germany
City
Muenchen
Country
Germany
City
Modena
Country
Italy
City
Roma
Country
Italy
City
Amsterdam
Country
Netherlands
City
Utrecht
Country
Netherlands
City
Almada
Country
Portugal
City
Barcelona
Country
Spain
City
Madrid
Country
Spain
City
Geneve
Country
Switzerland
City
Cardiff
Country
United Kingdom
City
Southhampton
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
18592619
Citation
Wollenberg A, Reitamo S, Girolomoni G, Lahfa M, Ruzicka T, Healy E, Giannetti A, Bieber T, Vyas J, Deleuran M; European Tacrolimus Ointment Study Group. Proactive treatment of atopic dermatitis in adults with 0.1% tacrolimus ointment. Allergy. 2008 Jul;63(7):742-50.
Results Reference
background
PubMed Identifier
18782316
Citation
Wollenberg A, Sidhu MK, Odeyemi I, Dorsch B, Koehne-Volland R, Schaff M, Ehlken B, Berger K. Economic evaluation of maintenance treatment with tacrolimus 0.1% ointment in adults with moderate to severe atopic dermatitis. Br J Dermatol. 2008 Dec;159(6):1322-30. doi: 10.1111/j.1365-2133.2008.08807.x. Epub 2008 Sep 6.
Results Reference
background
Links:
URL
http://www.clinicaltrials.jp/user/ctrSearch_e.jsp
Description
Link to Results on JAPIC - enter 140603 in the JapicCTI-RNo. field
Learn more about this trial
Treatment and Control of Atopic Dermatitis With 0.1% Tacrolimus Ointment
We'll reach out to this number within 24 hrs