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

University of Aberdeen

Status and phase

Completed

Phase 2

Conditions

Crohn Disease

Treatments

Drug: Tacrolimus

Study type

Interventional

Funder types

Other

Identifiers

33000332

Details and patient eligibility

About

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

Enrollment

20 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

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