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To Demonstrate the Superior Efficacy of NYC 0462 Ointment Over That of the Placebo in the Treatment of Plaque Psoriasis

Multi-Center, Double-Blind, Randomized, Vehicle-controlled, Parallel-Group Study Comparing NYC-0462 Ointment To a Vehicle Control

Status
Withdrawn
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00747032
Enrollment
0
Registered
2008-09-04
Start date
2010-09-30
Completion date
2011-04-30
Last updated
2012-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plaque Psoriasis

Brief 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.

Interventions

DRUGNYC 0462 Ointment

To assess the efficacy of NYC 0462 Ointment versus Placebo in the treatment of Plaque Psoriasis

DRUGPlacebo

To assess the efficacy of NYC 0462 Ointment versus Placebo in the treatment of Plaque Psoriasis

Sponsors

Fougera Pharmaceuticals Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Diagnosis of stable, symptomatic plaque psoriasis * Good health with the exception of psoriasis * % BSA and plaque elevation requirements

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
Reduction in plaque elevation score8 weeks

Secondary

MeasureTime frame
Reduction in Investigator´s Global Evaluation, erythema and scaling scores8 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026