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

Crohn Disease Clinical Trial

Official title:

Topical Tacrolimus 0.1% Ointment for Treatment of Cutaneous Crohn's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01233570
• Other study ID #: 33000332
• Status: Completed
• Phase: Phase 2
• First received: November 2, 2010
• Last updated: November 2, 2010

Study information

• Verified date: November 2010
• Source: University of Aberdeen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease

Intervention

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

Locations

Country	Name	City	State
United Kingdom	University of Aberdeen, Aberdeen Royal Infirmary	Aberdeen	Grampian

Sponsors (1)

Lead Sponsor	Collaborator
University of Aberdeen

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of standardised digital photography by three independent assessors following the Physicians' Global Severity Scale before and after treatment		At 12 weeks of treatment, optionally extended to 52 weeks	No
Secondary	Global Self Assessment		12 weeks, optionally extended to 52 weeks	No
Secondary	Perineal Disease Activity Index		12 weeks, optionally extended to 52 weeks	No