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

NCT01233570 | Completed Phase 2

• 1 other identifier: 33000332
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Crohn Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Global Self Assessment

  12 weeks, optionally extended to 52 weeks

• Perineal Disease Activity Index

  12 weeks, optionally extended to 52 weeks

Study Arms (1)

Topical tacrolimus

EXPERIMENTAL

Once daily topical application

Drug: Tacrolimus

Interventions

Tacrolimus DRUG

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

Also known as: Protopic 0.1%, FK506

Topical tacrolimus

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aberdeen: lead

Study Sites (1)

University of Aberdeen, Aberdeen Royal Infirmary

Aberdeen, Grampian, AB25 2ZN, United Kingdom

Location

MeSH Terms

Conditions

Crohn Disease; Pyoderma Gangrenosum

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Anthony D Ormerod, MBChB

  University of Aberdeen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 2, 2010
• First Posted: November 3, 2010
• Last Updated: November 3, 2010

Record last verified: 2010-11

Locations

GB (1)