Study to Compare U0267 Against Vehicle in Subjects With Plaque-type Psoriasis One of Two Phase 3 Studies

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to demonstrate the safety and efficacy of U0267 in subjects with plaque-type psoriasis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stiefel, a GSK Company
• Collaborator: GlaxoSmithKline

Criteria

Inclusion Criteria:

• Male or female subjects at least 12 years old and in good general health.

• Mild to moderate plaque-type psoriasis

Exclusion Criteria:

• Known allergy or other adverse reaction to calcipotriene or other vitamin D analogs; or to any component of the investigational formulations

• History of hypercalcemia or of vitamin D toxicity.

• Diagnosis of generalized pustular or erythrodermic exfoliative psoriasis.

• Other serious skin disorder or any chronic medical condition that is not well controlled.

• Use of non-biologic systemic anti-psoriatic therapy or biologic therapy within four weeks of enrollment.

• Use of topical therapies that have a known beneficial effect on psoriasis, within 2 weeks of enrollment.

• Systemic medications for other medical conditions that are known to affect psoriasis within the past four weeks of enrollment.

• Use of any investigational therapy within 4 weeks of enrollment.

• Pregnant women, women who are breast feeding, or sexually active women of child bearing potential who are not practicing an acceptable method of birth control.