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

Fougera Pharmaceuticals

Status and phase: Withdrawn; Phase 3

Conditions: Plaque Psoriasis

Treatments: Drug: NYC 0462 Ointment; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00747032

NYC 0462-01-01

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

0 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

NYC 0462 Ointment

Treatment:

Drug: NYC 0462 Ointment

2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo