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

Completed · Phase 3

Conditions studied: Psoriasis

In brief

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

Key facts

Study ID

NCT00688519

Run by

Stiefel, a GSK Company

People needed

336

Starts

2008-03-01

Expected to finish

2008-12-01

Last updated by the study team

2017-01-02

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female subjects at least 12 years old and in good general health.
• Mild to moderate plaque-type psoriasis

You may not qualify if…

• 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.

Where it is running

• Therapeutics Clinical Research Center, Inc. — San Diego, California, United States
• Cherry Creek Research, Inc. — Denver, Colorado, United States
• Florida Academic Dermatology Centers — Miami, Florida, United States
• FXM Research — Miami, Florida, United States
• DermResearch, PLLC — Louisville, Kentucky, United States
• Massachusetts General Hospital Clinical Unit for Research Trials in Skin — Boston, Massachusetts, United States
• Minnesota Clinical Study Center — Fridley, Minnesota, United States
• Mount Sinai School of Medicine, Department of Dermatology — New York, New York, United States
• Dermatology Consulting Services — High Point, North Carolina, United States
• Oregon Medical Research Center, P.C. — Portland, Oregon, United States
• Dermatology Treatment & Research Center — Dallas, Texas, United States
• The Center for Skin Research — Houston, Texas, United States
• Dermatology Research Center, Inc. — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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