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

This study has been completed.
Sponsor:
Information provided by:
University of Aberdeen
ClinicalTrials.gov Identifier:
NCT01233570
First received: November 2, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted
  Purpose

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


Condition Intervention Phase
Crohn Disease
 Drug: Tacrolimus
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Topical Tacrolimus 0.1% Ointment for Treatment of Cutaneous Crohn's Disease

Resource links provided by NLM:

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Tacrolimus
U.S. FDA Resources

Further study details as provided by University of Aberdeen:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Global Self Assessment [ Time Frame: 12 weeks, optionally extended to 52 weeks ] [ Designated as safety issue: No ]
  • Perineal Disease Activity Index [ Time Frame: 12 weeks, optionally extended to 52 weeks ] [ Designated as safety issue: No ]

Enrollment: 20
Arms Assigned Interventions
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:
  • Protopic 0.1%
  • FK506

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01233570

Locations
United Kingdom
University of Aberdeen, Aberdeen Royal Infirmary
Aberdeen, Grampian, United Kingdom, AB25 2ZN
Sponsors and Collaborators
University of Aberdeen
Investigators
Principal Investigator: Anthony D Ormerod, MBChB University of Aberdeen
  More Information

No publications provided

Responsible Party: Dr AD Ormerod, University of Aberdeen
ClinicalTrials.gov Identifier: NCT01233570     History of Changes
Other Study ID Numbers: 33000332
Study First Received: November 2, 2010
Last Updated: November 2, 2010
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Aberdeen:
Cutaneous Crohns Disease
Topical Tacrolimus
Protopic
Metastatic Crohns Disease
 Pyoderma Gangrenosum
Granulomatous chelitis
Oral crohns disease
Perianal crohns disease

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
 Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013