Topical Tacrolimus 0.1% Ointment For Treatment Of Cutaneous Crohn's Disease (NCT01233570) | Clinical Trial Compass
CompletedPhase 2
Topical Tacrolimus 0.1% Ointment For Treatment Of Cutaneous Crohn's Disease
United Kingdom20 participants
Plain-language summary
An assessment of the efficacy of topical tacrolimus in the treatment of cutaneous crohns disease
Who can participate
Age range12 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Assessment of standardised digital photography by three independent assessors following the Physicians' Global Severity Scale before and after treatment
Timeframe: At 12 weeks of treatment, optionally extended to 52 weeks