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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

An assessment of the efficacy of topical tacrolimus in the treatment of cutaneous crohns disease

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Aberdeen
• Treatments: Tacrolimus

Criteria

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