- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01233570
Topical Tacrolimus 0.1% Ointment For Treatment Of Cutaneous Crohn's Disease
November 2, 2010 updated by: University of Aberdeen
Topical Tacrolimus 0.1% Ointment for Treatment of Cutaneous Crohn's Disease
An assessment of the efficacy of topical tacrolimus in the treatment of cutaneous crohns disease
Study Overview
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Grampian
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Aberdeen, Grampian, United Kingdom, AB25 2ZN
- University of Aberdeen, Aberdeen Royal Infirmary
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- willingness and capability to follow the study procedure
- 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:
- known sensitivity to tacrolimus
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Topical tacrolimus
Once daily topical application
|
Once daily application for 12 weeks followed by 4 weeks observation.
Optional 36 week open label extension
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Assessment of standardised digital photography by three independent assessors following the Physicians' Global Severity Scale before and after treatment
Time Frame: At 12 weeks of treatment, optionally extended to 52 weeks
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At 12 weeks of treatment, optionally extended to 52 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Global Self Assessment
Time Frame: 12 weeks, optionally extended to 52 weeks
|
12 weeks, optionally extended to 52 weeks
|
Perineal Disease Activity Index
Time Frame: 12 weeks, optionally extended to 52 weeks
|
12 weeks, optionally extended to 52 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Anthony D Ormerod, MBChB, University of Aberdeen
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
November 2, 2010
First Submitted That Met QC Criteria
November 2, 2010
First Posted (ESTIMATE)
November 3, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
November 3, 2010
Last Update Submitted That Met QC Criteria
November 2, 2010
Last Verified
November 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Gastrointestinal Diseases
- Gastroenteritis
- Intestinal Diseases
- Inflammatory Bowel Diseases
- Crohn Disease
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Immunosuppressive Agents
- Immunologic Factors
- Calcineurin Inhibitors
- Tacrolimus
Other Study ID Numbers
- 33000332
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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