Topical Tacrolimus 0.1% Ointment For Treatment Of Cutaneous Crohn's Disease
NCT ID: NCT01233570
Last Updated: 2010-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
20 participants
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Topical tacrolimus
Once daily topical application
Tacrolimus
Once daily application for 12 weeks followed by 4 weeks observation. Optional 36 week open label extension
Interventions
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Tacrolimus
Once daily application for 12 weeks followed by 4 weeks observation. Optional 36 week open label extension
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* confirmed diagnosis of Crohn's Disease of at least 3 months duration confirmed by radiography, endoscopy or pathological examination
* required to have a skin manifestation of Crohn's disease
* required to give written informed consent
* both male and female subjects with reproductive potential required to be on an acceptable form of birth control for the duration of the study
* long-standing, concomitant immunosuppressive therapy was allowed if the dose was stable and not controlling the skin problem
Exclusion Criteria
* change in aminosalicylate dosage in the four weeks prior to screening
* on oral steroids at over 40mg per day
* been commenced on methotrexate, azathoprine or ciclosporin within the last two months
* commenced on a a TNF-alpha monoclonal antibody within the three months prior to screening
* patients having had a stoma fashioned less than three months before enrolment
* patients with an immunocompromising disease
* patients with a diagnosis of malignancy within the last five years
* patients with any other condition, past or present treatment thought by the investigator to render the subject ineligible for the study
12 Years
ALL
No
Sponsors
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University of Aberdeen
OTHER
Responsible Party
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University of Aberdeen
Principal Investigators
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Anthony D Ormerod, MBChB
Role: PRINCIPAL_INVESTIGATOR
University of Aberdeen
Locations
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University of Aberdeen, Aberdeen Royal Infirmary
Aberdeen, Grampian, United Kingdom
Countries
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Other Identifiers
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33000332
Identifier Type: -
Identifier Source: org_study_id