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Completed

NCT Number: NCT01233570

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

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Key information

Conditions

Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Pyoderma Pyoderma Gangrenosum Skin Diseases Skin Diseases, Vascular Skin Ulcer Skin and Connective Tissue Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Aberdeen, Aberdeen Royal Infirmary

Aberdeen, Grampian, AB25 2ZN, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tacrolimus

Drug

Once daily application for 12 weeks followed by 4 weeks observation. Optional 36 week open label extension

Other names: Protopic 0.1%, FK506

Primary outcomes

  1. 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 outcomes

  1. Global Self Assessment

    Time frame: 12 weeks, optionally extended to 52 weeks

  2. Perineal Disease Activity Index

    Time frame: 12 weeks, optionally extended to 52 weeks

Sponsors and collaborators

Lead sponsor

University of Aberdeen

Other

Registry information

Important dates

First posted
Nov 3, 2010
Registry last updated
Nov 3, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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