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

November 2, 2010 updated by: University of Aberdeen

Topical Tacrolimus 0.1% Ointment for Treatment of Cutaneous Crohn's Disease

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Grampian
      • Aberdeen, Grampian, United Kingdom, AB25 2ZN
        • University of Aberdeen, Aberdeen Royal Infirmary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Topical tacrolimus
Once daily topical application
Drug: Tacrolimus
Once daily application for 12 weeks followed by 4 weeks observation. Optional 36 week open label extension
Other Names:
  • FK506
  • Protopic 0.1%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
At 12 weeks of treatment, optionally extended to 52 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Global Self Assessment
Time Frame: 12 weeks, optionally extended to 52 weeks
12 weeks, optionally extended to 52 weeks
Perineal Disease Activity Index
Time Frame: 12 weeks, optionally extended to 52 weeks
12 weeks, optionally extended to 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aberdeen

Investigators

  • Principal Investigator: Anthony D Ormerod, MBChB, University of Aberdeen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 2010

First Submitted That Met QC Criteria

November 2, 2010

First Posted (ESTIMATE)

November 3, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

November 3, 2010

Last Update Submitted That Met QC Criteria

November 2, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 33000332

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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