Topical Tacrolimus 0.1% Ointment For Treatment Of Cutaneous Crohn's Disease

Study Overview
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Brief Summary
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An assessment of the efficacy of topical tacrolimus in the treatment of cutaneous crohns disease

Official Title
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Topical Tacrolimus 0.1% Ointment for Treatment of Cutaneous Crohn's Disease

Conditions
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Crohn Disease

Intervention / Treatment
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* Drug: Tacrolimus


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Topical tacrolimus<br>Once daily topical application | Drug: Tacrolimus<br>* Once daily application for 12 weeks followed by 4 weeks observation. Optional 36 week open label extension<br>* Other names: FK506;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of standardised digital photography by three independent assessors following the Physicians' Global Severity Scale before and after treatment |  | At 12 weeks of treatment, optionally extended to 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Self Assessment |  | 12 weeks, optionally extended to 52 weeks | 
| Perineal Disease Activity Index |  | 12 weeks, optionally extended to 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cutaneous Crohns Disease, Topical Tacrolimus, Protopic, Metastatic Crohns Disease, Pyoderma Gangrenosum, Granulomatous chelitis, Oral crohns disease, Perianal crohns disease