| May 29, 2008 |
| June 8, 2009 |
| April 2008 |
| December 2008 (final data collection date for primary outcome measure) |
| An ISGA score of clear (0) or almost clear (1), and A minimum improvement in the ISGA score of 2 grades from baseline to week 8. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00689481 on ClinicalTrials.gov Archive Site |
| A target lesion score of 0 or 1 for erythema and at least a 2 grade improvement from baseline; a target lesion score of 0 or 1 for scaling and at least a 2 grade improvement from baseline; a target lesion score of 0 for plaque thickness [ Time Frame: 8 weeks ] [ Designated as safety issue: No ] |
| Same as current |
| |
| Study to Compare U0267 Against Vehicle in Subjects With Plaque-Type Psoriasis |
| A Multicenter, Randomized, Double-Blind, Phase 3 Study of the Safety and Efficacy of Emulsion Formulation U0267 , Versus Vehicle Foam in Subjects With Plaque-Type Psoriasis |
The purpose of the study is to demonstrate the safety and efficacy of U0267 in subjects with plaque-type psoriasis. |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Plaque-Type Psoriasis |
- Drug: U0267
- Drug: Vehicle
|
- Experimental: U0267
- Placebo Comparator: Vehicle
|
| |
| |
| Completed |
| 330 |
| February 2009 |
| December 2008 (final data collection date for primary outcome measure) |
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.
|
| Both |
| 12 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00689481 |
| Jason Mann, Director, Global Clinical Operations, Stiefel Laboratories |
| U0267-302 |
| Stiefel, a GSK Company |
|
| Study Director: |
David A. Angulo, MD |
Stiefel Labortories, Inc. |
|
|
| Stiefel, a GSK Company |
| June 2009 |
