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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01233570
Recruitment Status : Completed
First Posted : November 3, 2010
Last Update Posted : November 3, 2010
Sponsor:
Information provided by:
University of Aberdeen

Tracking Information
First Submitted Date  ICMJE November 2, 2010
First Posted Date  ICMJE November 3, 2010
Last Update Posted Date November 3, 2010
Study Start Date  ICMJE Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: November 2, 2010)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 2, 2010)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Topical Tacrolimus 0.1% Ointment For Treatment Of Cutaneous Crohn's Disease
Official Title  ICMJE Topical Tacrolimus 0.1% Ointment for Treatment of Cutaneous Crohn's Disease
Brief Summary An assessment of the efficacy of topical tacrolimus in the treatment of cutaneous crohns disease
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Crohn Disease
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Topical tacrolimus
Once daily topical application
Intervention: Drug: Tacrolimus
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 2, 2010)
20
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01233570
Other Study ID Numbers  ICMJE 33000332
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr AD Ormerod, University of Aberdeen
Study Sponsor  ICMJE University of Aberdeen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Anthony D Ormerod, MBChB University of Aberdeen
PRS Account University of Aberdeen
Verification Date November 2010

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