PsoriasisPhase 3NCT00293891
A Study to Assess the Safety and Effectiveness of Tacrolimus Cream in the Treatment of Psoriasis
A Phase 3 study testing Tacrolimus Cream in people with Psoriasis, run by Astellas Pharma Inc at 33 sites in 2 countries.
Trial summary
A study to assess the safety and effectiveness of tacrolimus cream in the treatment of psoriasis. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- Tacrolimus Cream
- How many people
- 658 participants
- Where
- 33 sitesin 2 countries
- Study dates
- Start not givento Jan 2007
- Phase
- Phase 3
- 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
- Clinical diagnosis of plaque psoriasis
Who cannot join
- Skin disorder other than plaque psoriasis in the areas to be treated.
- Disease on only elbows, knees, and scalp
Trial locations and contacts
33 sites in 2 countries.
33 sites in 2 countries
United States27 sites
Study site
Ann Arbor, Michigan, 48109
Study site
Birmingham, Alabama, 35205
Study site
Columbus, Ohio, 43212
Study site
Dallas, Texas, 75390
Study site
Dayton, Ohio, 45408
Study site
Denver, Colorado, 80246
Study site
Durham, North Carolina, 27710
Study site
Houston, Texas, 77058
Study site
Indianapolis, Indiana, 46256
Study site
Knoxville, Tennessee, 37917
Study site
Little Rock, Arkansas, 72205
Study site
Louisville, Kentucky, 40217
Study site
Miami, Florida, 33144
Study site
Milwaukee, Wisconsin, 53209
Study site
New York, New York, 10032
Study site
Newnan, Georgia, 30263
Study site
Norfolk, Virginia, 23507
Study site
North Andover, Massachusetts, 01845
Study site
Omaha, Nebraska, 68144
Study site
Port Huron, Michigan, 48060
Study site
Portland, Oregon
Study site
Salt Lake City, Utah, 84132
Study site
San Antonio, Texas, 78229
Study site
San Diego, California, 92123
Study site
Seattle, Washington, 98101
Study site
St Louis, Missouri, 63110
Study site
West Palm Beach, Florida, 33407
Canada6 sites
Study site
Calgary, Alberta, T2S 3B3
Study site
Edmonton, Alberta, T5J 3S9
Study site
Laval, Quebec, H7S 2C6
Study site
Moncton, New Brunswick, E1C 8X3
Study site
Montreal, Quebec, H2K 4L5
Study site
Surrey, British Columbia, V3R
About this study
A study to assess the safety and effectiveness of tacrolimus cream in the treatment of psoriasis.
- Conditions
- Psoriasis
- Being tested
- Tacrolimus Cream
- Keywords
- Treatment Outcome, Tacrolimus, Safety, Psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tacrolimus CreamDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2006 (estimated)
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 658 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma US, Inc.
- Investigators
- J. Rico, MD, Study director, Astellas Pharma US, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00293891
- Sponsor's protocol ID
- 04-0-206
- Status last verified
- Dec 2007
- First submitted
- 16 Feb 2006
- Last updated
- 24 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Safety and Effectiveness of Tacrolimus Cream in the Treatment of Psoriasis
- ClinicalTrials.gov ID
- NCT00293891
- Acronym / sponsor ID
- 04-0-206
- Conditions
- Psoriasis
- Keywords
- Treatment Outcome, Tacrolimus, Safety, Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 658 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma US, Inc.
- Study completion
- Jan 2007 (actual)
- First posted
- 20 Feb 2006 (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.
A study to assess the safety and effectiveness of tacrolimus cream in the treatment of psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of plaque psoriasis
Key exclusion criteria (2 listed)
- Skin disorder other than plaque psoriasis in the areas to be treated.
- Disease on only elbows, knees, and scalp
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 |
|---|---|---|
| Tacrolimus Cream | Drug | – |
Primary outcome
Not reported in the source record.
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 24 Dec 2007.
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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.
J. Rico, MD study director
Astellas Pharma US, Inc.
33 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tacrolimus Cream in people with Psoriasis, run by Astellas Pharma Inc at 33 sites in 2 countries.
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 1 inclusion and 2 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 24 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States, Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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.
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 24 Dec 2007.