Plaque PsoriasisPhase 3NCT00747032
To Demonstrate the Superior Efficacy of NYC 0462 Ointment Over That of the Placebo in the Treatment of Plaque Psoriasis
A Phase 3 study testing NYC 0462 Ointment in people with Plaque Psoriasis, run by Fougera Pharmaceuticals Inc..
Trial summary
The aim of this trial is to assess the efficacy of NYC-0462 Ointment in the Treatment of Plaque Psoriasis.Treatment medication will be administered as follows: A thin layer of study product will be applied to the affected skin, excluding the face, once daily, at approximately the same time daily. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- NYC 0462 Ointment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2010to Apr 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of stable, symptomatic plaque psoriasis
- Good health with the exception of psoriasis
- % BSA and plaque elevation requirements
Who cannot join
- Subjects who are pregnant, nursing or planning a pregnancy within the study participation period.
- Subjects who have any systemic or dermatological disorders with the exception of psoriasis
About this study
Official title: Multi-Center, Double-Blind, Randomized, Vehicle-controlled, Parallel-Group Study Comparing NYC-0462 Ointment To a Vehicle Control
The aim of this trial is to assess the efficacy of NYC-0462 Ointment in the Treatment of Plaque Psoriasis.Treatment medication will be administered as follows: A thin layer of study product will be applied to the affected skin, excluding the face, once daily, at approximately the same time daily.
- Conditions
- Plaque Psoriasis
- Being tested
- NYC 0462 Ointment, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NYC 0462 OintmentDrug
To assess the efficacy of NYC 0462 Ointment versus Placebo in the treatment of Plaque Psoriasis
PlaceboDrug
To assess the efficacy of NYC 0462 Ointment versus Placebo in the treatment of Plaque Psoriasis
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | NYC 0462 Ointment Receives: Drug: NYC 0462 Ointment |
| 2 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in plaque elevation score
Measured: 8 weeks
Secondary outcomes (1)
Reduction in Investigator´s Global Evaluation, erythema and scaling scores
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 Sep 2008 (estimated)
- Study startSep 2010
- Primary completionFeb 2011 (estimated)
- Study completionApr 2011 (estimated)
Why it stopped: Study withdrawn due to business decisions. No subjects were treated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque 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
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fougera Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Kathleen Ocasio, Study chair, Fougera Pharmaceuticals Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00747032
- Sponsor's protocol ID
- NYC 0462-01-01
- Status last verified
- May 2012
- First submitted
- 1 Sep 2008
- Last updated
- 7 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center, Double-Blind, Randomized, Vehicle-controlled, Parallel-Group Study Comparing NYC-0462 Ointment To a Vehicle Control
- ClinicalTrials.gov ID
- NCT00747032
- Acronym / sponsor ID
- NYC 0462-01-01
- Conditions
- Plaque Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study withdrawn due to business decisions. No subjects were treated.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fougera Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Feb 2011 (estimated)
- Study completion
- Apr 2011 (estimated)
- First posted
- 4 Sep 2008 (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 aim of this trial is to assess the efficacy of NYC-0462 Ointment in the Treatment of Plaque Psoriasis.Treatment medication will be administered as follows: A thin layer of study product will be applied to the affected skin, excluding the face, once daily, at approximately the same time daily.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: NYC 0462 OintmentNYC 0462 Ointment |
| 2 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of stable, symptomatic plaque psoriasis
- Good health with the exception of psoriasis
- % BSA and plaque elevation requirements
Key exclusion criteria (2 listed)
- Subjects who are pregnant, nursing or planning a pregnancy within the study participation period.
- Subjects who have any systemic or dermatological disorders with the exception of 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 |
|---|---|---|
| NYC 0462 OintmentTo assess the efficacy of NYC 0462 Ointment versus Placebo in the treatment of Plaque Psoriasis | Drug | 1 |
| PlaceboTo assess the efficacy of NYC 0462 Ointment versus Placebo in the treatment of Plaque Psoriasis | Drug | 2 |
Primary outcome
Reduction in plaque elevation score
Time frame: 8 weeks
1 secondary outcome
Reduction in Investigator´s Global Evaluation, erythema and scaling scores
Time frame: 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2012.
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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.
Kathleen Ocasio study chair
Fougera Pharmaceuticals Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NYC 0462 Ointment in people with Plaque Psoriasis, run by Fougera Pharmaceuticals Inc..
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 3 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: withdrawn, as of the sponsor's last update on 7 May 2012. Status can change between updates, so confirm with the study contact before making plans.
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 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 was withdrawn before enrolling participants, so there are no results.
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?
Reduction in plaque elevation score (time frame: 8 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 7 May 2012.