Crohn DiseasePhase 2NCT01233570
Topical Tacrolimus 0.1% Ointment For Treatment Of Cutaneous Crohn's Disease
A Phase 2 study testing Tacrolimus in people with Crohn Disease, run by University of Aberdeen at 1 site in United Kingdom.
Trial summary
An assessment of the efficacy of topical tacrolimus in the treatment of cutaneous crohns disease Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Tacrolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Start not givento not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Aberdeen, Aberdeen Royal Infirmary
Aberdeen, Grampian, AB25 2ZN
About this study
Official title: 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
- Conditions
- Crohn Disease
- Being tested
- Tacrolimus
- Keywords
- Cutaneous Crohns Disease, Topical Tacrolimus, Protopic, Metastatic Crohns Disease, Pyoderma Gangrenosum, Granulomatous chelitis, Oral crohns disease, Perianal crohns disease
- Medical subject headings
- Crohn Disease, Pyoderma Gangrenosum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TacrolimusDrug
Also called Protopic 0.1%, FK506
Once daily application for 12 weeks followed by 4 weeks observation. Optional 36 week open label extension
| Study group | Role | What they receive |
|---|---|---|
| Topical tacrolimus | Experimental | Once daily topical application Receives: Drug: Tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of standardised digital photography by three independent assessors following the Physicians' Global Severity Scale before and after treatment
Measured: At 12 weeks of treatment, optionally extended to 52 weeks
Secondary outcomes (2)
Global Self Assessment
Measured: 12 weeks, optionally extended to 52 weeks
Perineal Disease Activity Index
Measured: 12 weeks, optionally extended to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Investigators
- Anthony D Ormerod, MBChB, Principal investigator, University of Aberdeen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01233570
- Sponsor's protocol ID
- 33000332
- Status last verified
- Nov 2010
- First submitted
- 2 Nov 2010
- Last updated
- 3 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Tacrolimus 0.1% Ointment for Treatment of Cutaneous Crohn's Disease
- ClinicalTrials.gov ID
- NCT01233570
- Acronym / sponsor ID
- 33000332
- Conditions
- Crohn Disease
- Keywords
- Cutaneous Crohns Disease, Topical Tacrolimus, Protopic, Metastatic Crohns Disease, Pyoderma Gangrenosum, Granulomatous chelitis, Oral crohns disease, Perianal crohns disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- First posted
- 3 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An assessment of the efficacy of topical tacrolimus in the treatment of cutaneous crohns disease
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Topical tacrolimus | Experimental | Drug: TacrolimusOnce daily topical application |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TacrolimusAlso: Protopic 0.1%, FK506Once daily application for 12 weeks followed by 4 weeks observation. Optional 36 week open label extension | Drug | Topical tacrolimus |
Primary outcome
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
2 secondary outcomes
Global Self Assessment
Time frame: 12 weeks, optionally extended to 52 weeks
Perineal Disease Activity Index
Time frame: 12 weeks, optionally extended to 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony D Ormerod, MBChB principal investigator
University of Aberdeen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tacrolimus in people with Crohn Disease, run by University of Aberdeen at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2010.