Study to Compare U0267 Against Vehicle in Subjects With Plaque-type Psoriasis One of Two Phase 3 Studies
- Registration Number
- NCT00688519
- Lead Sponsor
- Stiefel, a GSK Company
- Brief Summary
The purpose of the study is to demonstrate the safety and efficacy of U0267 in subjects with plaque-type psoriasis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 336
- Male or female subjects at least 12 years old and in good general health.
- Mild to moderate plaque-type psoriasis
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description U0267 Foam U0267 U0267 is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body. Vehicle foam Vehicle Vehicle foam is the same as the U0267 foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
- Primary Outcome Measures
Name Time Method Number of Subjects With Treatment Success, Assessed Per the Investigator's Static Global Assessment (ISGA) 8 weeks Assessment (on a scale of 0 to 4) was made as a visual average of all lesions, except those on the face/scalp. 0=clear; minor residual discoloration; no erythema/scaling/plaque thickness (PT). 1=almost clear; occasional fine scale/faint erythema/barely perceptible PT. 2=mild; fine scales predominate; light red coloration/mild PT. 3=moderate; coarse scales predominate; moderate red coloration/moderate PT. 4=severe; thick tenacious scale predominates; deep red coloration/severe PT. Treatment success=ISGA score 0 or 1, and a minimum improvement in the ISGA score of 2 grades from BL to week 8.
- Secondary Outcome Measures
Name Time Method Number of Subjects With a Target Lesion Score of 0 or 1 for Scaling and at Least a 2 Grade Improvement From Baseline at Week 8 8 weeks Scaling was assessed on a 6-point scale. 0=no evidence of scaling. 1=minimal; occasional fine scale over less than 5% of the lesion. 2=mild, fine scales predominate. 3=moderate; course scales predominate. 4=marked; thick non-tenacious scale predominates. 5=severe; very thick tenacious scale predominates.
Number of Subjects Who Have an ISGA Score of 0 or 1 at Week 8 8 weeks Assessment (on a scale of 0 to 4) was made as a visual average of all lesions, except those on the face/scalp. 0=clear; minor residual discoloration; no erythema/scaling/plaque thickness (PT). 1=almost clear; occasional fine scale/faint erythema/barely perceptible PT. 2=mild; fine scales predominate; light red coloration/mild PT. 3=moderate; coarse scales predominate; moderate red coloration/moderate PT. 4=severe; thick tenacious scale predominates; deep red coloration/severe PT.
Number of Subjects Who Have Treatment Success at Week 8 Analyzed by Baseline ISGA (Mild or Moderate) 8 weeks Assessment (on a scale of 0 to 4) was made as a visual average of all lesions, except those on the face/scalp. 0=clear; minor residual discoloration; no erythema/scaling/plaque thickness (PT). 1=almost clear; occasional fine scale/faint erythema/barely perceptible PT. 2=mild; fine scales predominate; light red coloration/mild PT. 3=moderate; coarse scales predominate; moderate red coloration/moderate PT. 4=severe; thick tenacious scale predominates; deep red coloration/severe PT. Treatment success=ISGA score 0 or 1, and a minimum improvement in the ISGA score of 2 grades from BL to week 8.
Number of Subjects With a Target Lesion Score of 0 or 1 for Erythema and at Least a 2-grade Improvement From Baseline at Week 8 8 weeks Erythema was assessed on a 6-point scale. 0=no evidence of erythema; hyperpigmentation may be present. 1=faint erythema. 2=light red coloration. 3=moderate red coloration. 4=bright red coloration. 5=dusky to deep red coloration.
Number of Subjects With a Target Lesion Score of 0 for Plaque Thickness at Week 8 8 weeks Plaque thickness was assessed on a 6-point scale. 0=no evidence of plaque thickness. 1=barely perceptible plaque thickness, approximately 0.5 millimeters (mm). 2=mild plaque thickness, approximately 1 mm. 3=moderate plaque thickness, approximately 1.5 mm. 4=marked plaque thickness, approximately 2 mm. 5=severe plaque thickness, approximately 2.5 mm or more.
Trial Locations
- Locations (13)
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
DermResearch, PLLC
🇺🇸Louisville, Kentucky, United States
Massachusetts General Hospital Clinical Unit for Research Trials in Skin
🇺🇸Boston, Massachusetts, United States
Dermatology Treatment & Research Center
🇺🇸Dallas, Texas, United States
Florida Academic Dermatology Centers
🇺🇸Miami, Florida, United States
FXM Research
🇺🇸Miami, Florida, United States
The Center for Skin Research
🇺🇸Houston, Texas, United States
Therapeutics Clinical Research Center, Inc.
🇺🇸San Diego, California, United States
Dermatology Research Center, Inc.
🇺🇸Salt Lake City, Utah, United States
Cherry Creek Research, Inc.
🇺🇸Denver, Colorado, United States
Oregon Medical Research Center, P.C.
🇺🇸Portland, Oregon, United States