Topical Tacrolimus 0.1% Ointment For Treatment Of Cutaneo... | NCT01233570

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

NCT01233570

Sponsor

University of Aberdeen

Status

Completed

Last Update Posted

Nov 3, 2010Estimated

Enrollment

20Actual

Phase

Phase 2

Conditions

Crohn Disease

Interventions

Tacrolimus

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Nov 2, 2010

First Submission Date that Met QC Criteria

Nov 2, 2010

First Posted Date

Nov 3, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 2, 2010

Last Update Posted Date

Nov 3, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Topical tacrolimus	Experimental	Once daily topical application	Drug: Tacrolimus

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tacrolimus	Drug	Once daily application for 12 weeks followed by 4 weeks observation. Optional 36 week open label extension	Topical tacrolimus

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Global Self Assessment		12 weeks, optionally extended to 52 weeks
Perineal Disease Activity Index		12 weeks, optionally extended to 52 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Anthony D Ormerod, MBChB	University of Aberdeen	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Aberdeen, Aberdeen Royal Infirmary		Aberdeen	Grampian	AB25 2ZN	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D003424	Crohn Disease
D017511	Pyoderma Gangrenosum

Ancestor Terms

ID	Term
D015212	Inflammatory Bowel Diseases
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Term
D018942	Macrolides
D007783	Lactones
D009930	Organic Chemicals