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

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00689481
• Other study ID #: 114742
• Secondary ID: U0267-302
• Status: Completed
• Phase: Phase 3
• First received: May 29, 2008
• Last updated: April 5, 2012
• Start date: March 2008
• Est. completion date: December 2008

Study information

• Verified date: April 2012
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 323
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• U0267 Foam
All treatments will be administered topically twice daily (morning and evening) for 8 weeks to areas affected with psoriasis (excluding face and scalp).
• Vehicle foam
All treatments will be administered topically twice daily (morning and evening) for 8 weeks to areas affected with psoriasis (excluding face and scalp).

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Stiefel, a GSK Company	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects With Treatment Success, Assessed Per the Investigator's Static Global Assessment	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.	8 weeks	No
Secondary	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	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.	8 Weeks	No
Secondary	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	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.	8 Weeks	No
Secondary	Number of Subjects With a Target Lesion Score of 0 for Plaque Thickness at Week 8	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.	8 Weeks	No
Secondary	Number of Subjects Who Have an ISGA Score of 0 or 1 at Week 8	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.	8 Weeks	No
Secondary	Number of Subjects Who Have Treatment Success at Week 8 Analyzed by Baseline ISGA (Mild or Moderate)	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.	8 Weeks	No