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Study to Compare U0267 Against Vehicle in Subjects With Plaque-type Psoriasis One of Two Phase 3 Studies
Study to Compare U0267 Against Vehicle in Subjects With Plaque-type Psoriasis One of Two Phase 3 Studies
CompletedPhase 3
Sponsor: Stiefel, a GSK Company
Conditions: Psoriasis
Interventions: U0267, Vehicle
Countries: United States
The purpose of the study is to demonstrate the safety and efficacy of U0267 in subjects with plaque-type psoriasis.
Eligibility overview
Sex: ALL
Age: 12 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Eligibility 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.
Locations (13)
- San Diego, California, United States
- Denver, Colorado, United States
- Miami, Florida, United States
- Miami, Florida, United States
- Louisville, Kentucky, United States
- Boston, Massachusetts, United States
- Fridley, Minnesota, United States
- New York, New York, United States
- High Point, North Carolina, United States
- Portland, Oregon, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Salt Lake City, Utah, United States