Psoriasis VulgarisPhase 2NCT01465282
Evaluation of the Efficacy, Safety and Toleration of CT327 Ointment in Patients With Psoriasis Vulgaris
A Phase 2 study testing CT327 0.05%, CT327 0.1% and CT327 0.5% in people with Psoriasis Vulgaris, run by Creabilis SA at 13 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the effectiveness of 3 dose strengths of CT327 ointment (0.05%, 0.1% and 0.05% w/w) compared to a placebo, when applied twice daily for up to 8 weeks, to the psoriatic plaques of patients with psoriasis vulgaris. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- CT327 0.05%, CT327 0.1% and CT327 0.5%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 13 sitesin 2 countries
- Study dates
- Dec 2011to Sep 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects aged at least 18 years.
- Stable psoriasis vulgaris
Who cannot join
- Subjects with guttate, erythrodermic, exfoliative or pustular psoriasis.
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States8 sites
Study site
Bay City, Michigan
Study site
Fridley, Minnesota
Study site
Hotsprings, Arkansas
Study site
Portland, Oregon
Study site
San Antonio, Texas
Study site
San Ramon, California
Study site
South Euclid, Ohio
Study site
Spanish Fork, Utah
United Kingdom5 sites
Study site
Birmingham
Study site
Cardiff
Study site
Glasgow
Study site
Manchester
Study site
Merseyside
About this study
Official title: A Randomized, Placebo-controlled, Phase IIb Study to Evaluate the Efficacy, Safety and Tolerability of 0.05%, 0.1% and 0.5% w/w Topical CT327 When Applied Twice Daily in Subjects With Psoriasis Vulgaris
The purpose of this study is to evaluate the effectiveness of 3 dose strengths of CT327 ointment (0.05%, 0.1% and 0.05% w/w) compared to a placebo, when applied twice daily for up to 8 weeks, to the psoriatic plaques of patients with psoriasis vulgaris.
- Conditions
- Psoriasis Vulgaris
- Being tested
- CT327 0.05%, CT327 0.1%, CT327 0.5%, Placebo
- Keywords
- psoriasis vulgaris, topical ointment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT327 0.05%Drug
0.05% CT327 (w/w) ointment
CT327 0.1%Drug
0.1% CT327 (w/w) ointment
CT327 0.5%Drug
0.5% CT327 (w/w) ointment
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 0.05% (w/w) CT327 ointment | Experimental | 0.05% (w/w) CT327 ointment applied BID for up to 8 weeks. Receives: Drug: CT327 0.05% |
| 0.1% (w/w) CT327 ointment | Experimental | 0.1% (w/w) CT327 ointment applied BID for up to 8 weeks. Receives: Drug: CT327 0.1% |
| 0.5% (w/w) CT327 ointment | Experimental | 0.5% (w/w) CT327 ointment applied BID for up to 8 weeks. Receives: Drug: CT327 0.5% |
| Placebo ointment | Placebo comparator | Placebo ointment Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of CT327 ointment (0.05%, 0.1% and 0.5% w/w) compared with placebo ointment.
Measured: Week 8
Secondary outcomes (1)
Local and systemic toleration
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2011 (estimated)
- Study startDec 2011
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis VulgarisStudies 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
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Creabilis SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01465282
- Sponsor's protocol ID
- CT327-2003
- Status last verified
- Mar 2013
- First submitted
- 1 Nov 2011
- Last updated
- 8 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled, Phase IIb Study to Evaluate the Efficacy, Safety and Tolerability of 0.05%, 0.1% and 0.5% w/w Topical CT327 When Applied Twice Daily in Subjects With Psoriasis Vulgaris
- ClinicalTrials.gov ID
- NCT01465282
- Acronym / sponsor ID
- CT327-2003
- Conditions
- Psoriasis Vulgaris
- Keywords
- psoriasis vulgaris, topical ointment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Creabilis SAIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 4 Nov 2011 (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.
The purpose of this study is to evaluate the effectiveness of 3 dose strengths of CT327 ointment (0.05%, 0.1% and 0.05% w/w) compared to a placebo, when applied twice daily for up to 8 weeks, to the psoriatic plaques of patients with psoriasis vulgaris.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 0.05% (w/w) CT327 ointment | Experimental | Drug: CT327 0.05%0.05% (w/w) CT327 ointment applied BID for up to 8 weeks. |
| 0.1% (w/w) CT327 ointment | Experimental | Drug: CT327 0.1%0.1% (w/w) CT327 ointment applied BID for up to 8 weeks. |
| 0.5% (w/w) CT327 ointment | Experimental | Drug: CT327 0.5%0.5% (w/w) CT327 ointment applied BID for up to 8 weeks. |
| Placebo ointment | Placebo comparator | Drug: PlaceboPlacebo ointment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male and female subjects aged at least 18 years.
- Stable psoriasis vulgaris
Key exclusion criteria (1 listed)
- Subjects with guttate, erythrodermic, exfoliative or pustular psoriasis.
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 |
|---|---|---|
| CT327 0.05%0.05% CT327 (w/w) ointment | Drug | 0.05% (w/w) CT327 ointment |
| CT327 0.1%0.1% CT327 (w/w) ointment | Drug | 0.1% (w/w) CT327 ointment |
| CT327 0.5%0.5% CT327 (w/w) ointment | Drug | 0.5% (w/w) CT327 ointment |
| PlaceboPlacebo | Drug | Placebo ointment |
Primary outcome
Efficacy of CT327 ointment (0.05%, 0.1% and 0.5% w/w) compared with placebo ointment.
Time frame: Week 8
1 secondary outcome
Local and systemic toleration
Time frame: 8 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 8 Mar 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CT327 0.05%, CT327 0.1% and CT327 0.5% in people with Psoriasis Vulgaris, run by Creabilis SA at 13 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 2 inclusion and 1 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 8 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, 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. Some participants in this study may receive a placebo. 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?
Efficacy of CT327 ointment (0.05%, 0.1% and 0.5% w/w) compared with placebo ointment. (time frame: Week 8). 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 8 Mar 2013.