Status:
COMPLETED
Study to Compare U0267 Against Vehicle in Subjects With Plaque-type Psoriasis One of Two Phase 3 Studies
Lead Sponsor:
Stiefel, a GSK Company
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Psoriasis
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
The purpose of the study is to demonstrate the safety and efficacy of U0267 in subjects with plaque-type psoriasis.
Eligibility Criteria
Inclusion
- Male or female subjects at least 12 years old and in good general health.
- Mild to moderate plaque-type psoriasis
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
336 Patients enrolled
Trial Details
Trial ID
NCT00688519
Start Date
March 1 2008
End Date
December 1 2008
Last Update
January 2 2017
Active Locations (13)
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1
Therapeutics Clinical Research Center, Inc.
San Diego, California, United States, 92123
2
Cherry Creek Research, Inc.
Denver, Colorado, United States, 80209
3
Florida Academic Dermatology Centers
Miami, Florida, United States, 33136
4
FXM Research
Miami, Florida, United States, 33175