Crohn Disease
Conditions
Keywords
Cutaneous Crohns Disease, Topical Tacrolimus, Protopic, Metastatic Crohns Disease, Pyoderma Gangrenosum, Granulomatous chelitis, Oral crohns disease, Perianal crohns disease
Brief summary
An assessment of the efficacy of topical tacrolimus in the treatment of cutaneous crohns disease
Interventions
DRUGTacrolimus
Once daily application for 12 weeks followed by 4 weeks observation. Optional 36 week open label extension
Sponsors
University of Aberdeen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Global Self Assessment | 12 weeks, optionally extended to 52 weeks |
| Perineal Disease Activity Index | 12 weeks, optionally extended to 52 weeks |
Countries
United Kingdom
Outcome results
None listed