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

Overview

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

Full Title of Study: “Topical Tacrolimus 0.1% Ointment for Treatment of Cutaneous Crohn’s Disease”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)

Interventions

  • Drug: Tacrolimus
    • Once daily application for 12 weeks followed by 4 weeks observation. Optional 36 week open label extension

Arms, Groups and Cohorts

  • Experimental: Topical tacrolimus
    • Once daily topical application

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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

Participating in This Clinical Trial

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
  • Gender Eligibility: All

    Minimum Age: 12 Years

    Maximum Age: N/A

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • University of Aberdeen
    • Provider of Information About this Clinical Study
      • Dr AD Ormerod, University of Aberdeen
    • Overall Official(s)
      • Anthony D Ormerod, MBChB, Principal Investigator, University of Aberdeen

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