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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01233570
• Date of registration: 02/11/2010
• Prospective Registration: No
• Primary sponsor: University of Aberdeen
• Public title: Topical Tacrolimus 0.1% Ointment For Treatment Of Cutaneous Crohn's Disease
• Scientific title: Topical Tacrolimus 0.1% Ointment for Treatment of Cutaneous Crohn's Disease
• Date of first enrolment: September 2010
• Target sample size: 20
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01233570
• Study type: Interventional
• Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

United Kingdom

Contacts

• Name: Anthony D Ormerod, MBChB
• Affiliation: University of Aberdeen

Key inclusion & exclusion 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



Age minimum: 12 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Crohn Disease

Intervention(s)

Drug: Tacrolimus

Primary Outcome(s)

Assessment of standardised digital photography by three independent assessors following the Physicians' Global Severity Scale before and after treatment [Time Frame: At 12 weeks of treatment, optionally extended to 52 weeks]

Secondary Outcome(s)

Global Self Assessment [Time Frame: 12 weeks, optionally extended to 52 weeks]

Perineal Disease Activity Index [Time Frame: 12 weeks, optionally extended to 52 weeks]

Secondary ID(s)

33000332

Source(s) of Monetary Support

Please refer to primary and secondary sponsors