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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

November 2, 2010
November 2, 2010
Not Provided
Not Provided
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 ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
Topical Tacrolimus 0.1% Ointment For Treatment Of Cutaneous Crohn's Disease
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
Not Provided
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Crohn Disease
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
Experimental: Topical tacrolimus
Once daily topical application
Intervention: Drug: Tacrolimus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
Not Provided
Not Provided

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
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01233570
33000332
No
Dr AD Ormerod, University of Aberdeen
University of Aberdeen
Not Provided
Principal Investigator: Anthony D Ormerod, MBChB University of Aberdeen
University of Aberdeen
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP