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

Phase 3

Completed

Conditions: Psoriasis

Interventions: Drug: U0267 Foam
Drug: Vehicle foam

Registration Number: NCT00689481

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: 323

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
U0267 foam	U0267 Foam	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 foam	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	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 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 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 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.
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.

Trial Locations

Locations (12): Advanced Dermatology & Cosmetic Surgery
🇺🇸
Ormond Beach, Florida, United States
Center for Dermatology Cosmetic and Laser Surgery
🇺🇸
Fremont, California, United States
Coastal Clinical Research, Inc.
🇺🇸
Mobile, Alabama, United States
Academic Dermatology Associates
🇺🇸
Albuquerque, New Mexico, United States
The Center for Dermatology at Lifetime Health
🇺🇸
Rochester, New York, United States
Clinical Partners, LLC
🇺🇸
Johnston, Rhode Island, United States
University Dermatology Consultants, Inc.
🇺🇸
Cincinnati, Ohio, United States
The Skin Wellness Center, PC
🇺🇸
Knoxville, Tennessee, United States
Dermatology Clinical Research Center of San Antonio
🇺🇸
San Antonio, Texas, United States
Adult & Pediatric Dermatology
🇺🇸
Overland Park, Kansas, United States
Oregon Dermatology and Research Center
🇺🇸
Portland, Oregon, United States
Wake Forest University Health Sciences
🇺🇸
Winston Salem, North Carolina, United States