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CompletedNCT01233570Updated Nov 3, 2010

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

A Phase 2 interventional study of Tacrolimus in Crohn Disease, sponsored by University of Aberdeen. Completed at 1 site in United Kingdom. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2010-11-03.

Sponsored by University of Aberdeen · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
12 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Crohn Disease

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Keywords

  • Cutaneous Crohns Disease
  • Topical Tacrolimus
  • Protopic
  • Metastatic Crohns Disease
  • Pyoderma Gangrenosum
  • Granulomatous chelitis
  • Oral crohns disease
  • Perianal crohns disease
03

In context

Crohn Disease

1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.

This study's enrollment of 20 is below the median of 66 across 1,188 interventional studies indexed under Crohn Disease.

Browse Crohn Disease studies →

Lead sponsor

University of Aberdeen is the lead sponsor of 170 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Topical tacrolimus

    Once daily topical application

    Drug: Tacrolimus

Interventions

  • DrugTacrolimus

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

    Also known as: Protopic 0.1%, FK506

06

What researchers measure

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

07

Study locations

1 site
  • University of Aberdeen, Aberdeen Royal Infirmary
    Aberdeen, Grampian AB25 2ZN, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 3, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01233570
Lead sponsor
University of Aberdeen
First posted
Nov 3, 2010
Last update
Nov 3, 2010

Study contacts

Anthony D Ormerod, MBChB
principal investigator · University of Aberdeen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2010. You cannot join it, but the record below documents what was studied.

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