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

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

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