PsoriasisPhase 3NCT00293917
A Study to Assess the Long-Term Safety 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 37 sites in 2 countries.
Trial summary
A study to assess the long-term safety 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
- 37 sitesin 2 countries
- Study dates
- Jan 2006to Aug 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 scalp
Trial locations and contacts
37 sites in 2 countries.
37 sites in 2 countries
United States31 sites
Study site
Arlington, Texas, 76011
Study site
Atlanta, Georgia, 30322
Study site
Bellingham, Washington, 98225
Study site
Birmingham, Alabama, 30322
Study site
Boise, Idaho, 83704
Study site
Boston, Massachusetts, 02118
Study site
Chicago, Illinois, 60614
Study site
Chicago, Illinois
Study site
Detroit, Michigan, 48202
Study site
East Setauket, New York, 11733
Study site
East Windsor, New Jersey, 08520
Study site
Fresno, California, 93710
Study site
Goodlettsville, Tennessee, 37072
Study site
Hershey, Pennsylvania, 17033
Study site
Houston, Texas, 77056
Study site
Jacksonville, Florida, 32204
Study site
Kenatchee, Washington, 98801
Study site
Lebanon, New Hampshire, 03756
Study site
Lincoln, Nebraska, 68502
Study site
Louisville, Kentucky, 40202
Study site
Miami, Florida
Study site
Minneapolis, Minnesota, 55455
Study site
New Orleans, Louisiana, 70112
Study site
New York, New York, 10016
Study site
New York, New York, 10025
Study site
Newnan, Georgia, 30263
Study site
Reno, Nevada, 89511
Study site
Santa Monica, California, 90404
Study site
Simpsonville, South Carolina, 29681
Study site
Spokane, Washington, 99202
Study site
Vista, California, 92083
Canada6 sites
Study site
Halifax, Nova Scotia, B3H 1Z4
Study site
Hamilton, Ontario, L8N 1V6
Study site
Markham, Ontario, L3P 1AB
Study site
St. John's, Newfoundland and Labrador, A1B 3E1
Study site
Windsor, Ontario, N8W 5L7
Study site
Winnipeg, Manitoba, R3C 1R4
About this study
Official title: A Phase 3, Long-Term, Open Label Study to Evaluate the Safety of Twice Daily Tacrolimus Cream-B 0.1% in the Treatment of Psoriasis
A study to assess the long-term safety of tacrolimus cream in the treatment of psoriasis
Read the detailed description
A long-term, open label, non-comparative, multi-center study to evaluate the safety of tacrolimus cream-B 0.1% in treating the signs and symptoms 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Measured: 12 months
Secondary outcomes (1)
Efficacy
Measured: 12 months
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 startJan 2006
- Primary completionAug 2007
- Study completionAug 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 658 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma US, Inc.
- Investigators
- M Rico, MD, Study director, Astellas Pharma US, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00293917
- Sponsor's protocol ID
- 04-0-207
- Status last verified
- Feb 2008
- First submitted
- 16 Feb 2006
- Last updated
- 13 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Long-Term, Open Label Study to Evaluate the Safety of Twice Daily Tacrolimus Cream-B 0.1% in the Treatment of Psoriasis
- ClinicalTrials.gov ID
- NCT00293917
- Acronym / sponsor ID
- 04-0-207
- 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 start
- Jan 2006
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 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 long-term safety of tacrolimus cream in the treatment of psoriasis
Detailed description
A long-term, open label, non-comparative, multi-center study to evaluate the safety of tacrolimus cream-B 0.1% in treating the signs and symptoms of psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
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 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
Safety
Time frame: 12 months
1 secondary outcome
Efficacy
Time frame: 12 months
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 13 Feb 2008.
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Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
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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.
M Rico, MD study director
Astellas Pharma US, Inc.
37 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 37 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 13 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 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.
What does the primary outcome measure?
Safety (time frame: 12 months). 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 13 Feb 2008.