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

Primary Purpose

Crohn Disease

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Tacrolimus
Sponsored by
University of Aberdeen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn Disease focused on measuring Cutaneous Crohns Disease, Topical Tacrolimus, Protopic, Metastatic Crohns Disease, Pyoderma Gangrenosum, Granulomatous chelitis, Oral crohns disease, Perianal crohns disease

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Aberdeen, Aberdeen Royal Infirmary

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Topical tacrolimus

Arm Description

Once daily topical application

Outcomes

Primary Outcome Measures

Assessment of standardised digital photography by three independent assessors following the Physicians' Global Severity Scale before and after treatment

Secondary Outcome Measures

Global Self Assessment
Perineal Disease Activity Index

Full Information

First Posted
November 2, 2010
Last Updated
November 2, 2010
Sponsor
University of Aberdeen
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1. Study Identification

Unique Protocol Identification Number
NCT01233570
Brief Title
Topical Tacrolimus 0.1% Ointment For Treatment Of Cutaneous Crohn's Disease
Official Title
Topical Tacrolimus 0.1% Ointment for Treatment of Cutaneous Crohn's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Aberdeen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease
Keywords
Cutaneous Crohns Disease, Topical Tacrolimus, Protopic, Metastatic Crohns Disease, Pyoderma Gangrenosum, Granulomatous chelitis, Oral crohns disease, Perianal crohns disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Topical tacrolimus
Arm Type
Experimental
Arm Description
Once daily topical application
Intervention Type
Drug
Intervention Name(s)
Tacrolimus
Other Intervention Name(s)
Protopic 0.1%, FK506
Intervention Description
Once daily application for 12 weeks followed by 4 weeks observation. Optional 36 week open label extension
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Global Self Assessment
Time Frame
12 weeks, optionally extended to 52 weeks
Title
Perineal Disease Activity Index
Time Frame
12 weeks, optionally extended to 52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony D Ormerod, MBChB
Organizational Affiliation
University of Aberdeen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Aberdeen, Aberdeen Royal Infirmary
City
Aberdeen
State/Province
Grampian
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom

12. IPD Sharing Statement

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

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