PsoriasisPhase 2NCT00384098
Safety and Efficacy of Topically Applied CTA018 in Plaque Psoriasis
A Phase 2 study testing CTA018 cream in people with Psoriasis, run by OPKO Health, Inc. at 16 sites in United States.
Trial summary
Vitamin D and its analogs are currently widely used for the treatment of psoriasis. The study drug (CTA018) is a novel analog of vitamin D, and this Phase 2 study will investigate the efficacy and safety of CTA018 in the treatment of psoriasis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- CTA018 cream
- How many people
- 140 participants
- Where
- 16 sitesUnited States
- Study dates
- Sep 2006to May 2007
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical diagnosis of chronic plaque psoriasis for 6 months to a max 15% body surface area excluding face, scalp, groin, axillae, palms, soles of feet
- at least two evaluable plaques with CPSS >/= 6
- baseline PSGA >/= 2
- women of childbearing potential msut agree to use an effective form of contraception
Who cannot join
- cannot have guttate, pustular, erythrodermic or other non-plaque forms of psoriasis
- cannot have concomitant serious illness/condition that may interfere with participation in the study
- cannot have used topical therapy within 2 weeks prior to baseline visit
- cannot have used photo-therapy or systemic psoriasis therapy within 4 weeks prior to baseline visit
- cannot have had prolonged exposure to natural or artificial UV radiation within 4 weeks of baseline visit or intend to have exposure during the study
- cannot have used systemic immunomodulatory therapy within 12 weeks prior to baseline visit
Show all 10Show fewer
- cannot have a history of hypercalcemia or kidney stones
- cannot be unable or unwilling to discontinue calcium and/or vitamin D supplementation during the study
- cannot be pregnant or a nursing mother
- cannot be participating in or have participated in an interventional study within 30 days of study start
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Radiant Research Inc.
Anderson, South Carolina, 29621
Mass General/ Brigham & Women's
Boston, Massachusetts, 02215
Northwestern University
Chicago, Illinois, 60611
Radiant Research
Cincinnati, Ohio, 45249
University Hospitals of Cleveland
Cleveland, Ohio, 44106
Palmetto Clinical Trial Services LLC
Greenville, South Carolina, 29607
Dermatology Research of Arkansas PLLC
Little Rock, Arkansas, 72205
UMDNJ-Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08903
New York University Medical Center
New York, New York, 10016
Mount Sinai School of Medicine
New York, New York, 10029
Radiant Research, Kansas City
Overland Park, Kansas, 66215
Paddington Testing Co.
Philadelphia, Pennsylvania, 19103
Department of Dermatology, Mayo Clinic
Rochester, Minnesota, 55905
Radiant Research
Tucson, Arizona, 85710
Buffalo Medical Group PC
Williamsville, New York, 14221
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: A Randomized, Double-blind, Parallel-group, 4-arm, 12-week Study to Evaluate the Safety and Efficacy of Topically Applied CTA018 vs Vehicle for the Treatment of Adult Subjects With Chronic Plaque Psoriasis
Vitamin D and its analogs are currently widely used for the treatment of psoriasis. The study drug (CTA018) is a novel analog of vitamin D, and this Phase 2 study will investigate the efficacy and safety of CTA018 in the treatment of psoriasis. Patients with chronic plaque psoriasis will receive one of three doses of CTA018 cream or vehicle (no study drug) daily for 12 weeks.
- Conditions
- Psoriasis
- Being tested
- CTA018 cream
- Keywords
- Psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTA018 creamDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint will be treatment success or failure based on a Physician's Static Global Assessment (PSGA) of 0 or 1 (success).
Secondary outcomes (1)
Secondary efficacy outcomes include time to success (PSGA), change in overall PSGA score, and Area Adjusted Psoriasis Area and Severity Index (AAPASI)changes from baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2006 (estimated)
- Study startSep 2006
- Primary completionMay 2007
- Study completionMay 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 140 participants
Sponsor and investigators
- Lead sponsor
- OPKO Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joel Melnick, MD, Study director, OPKO Renal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00384098
- Sponsor's protocol ID
- CTA018-CL-2001
- Status last verified
- Jun 2007
- First submitted
- 2 Oct 2006
- Last updated
- 29 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Parallel-group, 4-arm, 12-week Study to Evaluate the Safety and Efficacy of Topically Applied CTA018 vs Vehicle for the Treatment of Adult Subjects With Chronic Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT00384098
- Acronym / sponsor ID
- CTA018-CL-2001
- Conditions
- Psoriasis
- Keywords
- Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants
- Lead sponsor
- OPKO Health, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 4 Oct 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.
Vitamin D and its analogs are currently widely used for the treatment of psoriasis. The study drug (CTA018) is a novel analog of vitamin D, and this Phase 2 study will investigate the efficacy and safety of CTA018 in the treatment of psoriasis. Patients with chronic plaque psoriasis will receive one of three doses of CTA018 cream or vehicle (no study drug) daily for 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- clinical diagnosis of chronic plaque psoriasis for 6 months to a max 15% body surface area excluding face, scalp, groin, axillae, palms, soles of feet
- at least two evaluable plaques with CPSS >/= 6
- baseline PSGA >/= 2
- women of childbearing potential msut agree to use an effective form of contraception
Key exclusion criteria (10 listed)
- cannot have guttate, pustular, erythrodermic or other non-plaque forms of psoriasis
- cannot have concomitant serious illness/condition that may interfere with participation in the study
- cannot have used topical therapy within 2 weeks prior to baseline visit
- cannot have used photo-therapy or systemic psoriasis therapy within 4 weeks prior to baseline visit
- cannot have had prolonged exposure to natural or artificial UV radiation within 4 weeks of baseline visit or intend to have exposure during the study
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 |
|---|---|---|
| CTA018 cream | Drug | – |
Primary outcome
The primary endpoint will be treatment success or failure based on a Physician's Static Global Assessment (PSGA) of 0 or 1 (success).
1 secondary outcome
Secondary efficacy outcomes include time to success (PSGA), change in overall PSGA score, and Area Adjusted Psoriasis Area and Severity Index (AAPASI)changes from baseline.
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 29 Sep 2014.
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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.
Joel Melnick, MD study director
OPKO Renal
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CTA018 cream in people with Psoriasis, run by OPKO Health, Inc. at 16 sites in United States.
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 4 inclusion and 10 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 29 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. 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?
The primary endpoint will be treatment success or failure based on a Physician's Static Global Assessment (PSGA) of 0 or 1 (success).. 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 29 Sep 2014; AzTrials last refreshed its copy on 8 Nov 2026.