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

Sponsor:	Stiefel, a GSK Company
Collaborator:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00689481

Purpose

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

Condition	Intervention	Phase
Plaque-type Psoriasis	Drug: U0267 Foam Drug: Vehicle foam	Phase III

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

Resource links provided by NLM:

Genetics Home Reference related topics: psoriatic arthritis

MedlinePlus related topics: Psoriasis

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Treatment Sucess [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Erythema [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
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
Scaling [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
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
Plaque Thickness [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
Number of subjects with a target lesion score of 0 for plaque thickness at week 8
ISGA (Investigator Static Global Assessment) [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
Number of subjects who have an ISGA score of 0 or 1 at week 8
Treatment Sucess by Baseline ISGA Score [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
Number of subjects who have treatment sucess at week 8 analyzed by baseline ISGA (Mild or Moderate)

Enrollment:	330
Study Start Date:	April 2008
Study Completion Date:	February 2009
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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.	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).
Placebo Comparator: 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.	Drug: 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).

Eligibility

Criteria

Inclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00689481

Locations

United States, Alabama
Coastal Clinical Research, Inc.
Mobile, Alabama, United States, 36608
United States, California
Center for Dermatology Cosmetic and Laser Surgery
Fremont, California, United States, 94538
United States, Florida
Advanced Dermatology & Cosmetic Surgery
Ormond Beach, Florida, United States, 32175
United States, Kansas
Adult & Pediatric Dermatology
Overland Park, Kansas, United States, 66211
United States, New Mexico
Academic Dermatology Associates
Albuquerque, New Mexico, United States, 87106
United States, New York
The Center for Dermatology at Lifetime Health
Rochester, New York, United States, 14623
United States, North Carolina
Wake Forest University Health Sciences
Winston Salem, North Carolina, United States, 27157
United States, Ohio
University Dermatology Consultants, Inc.
Cincinnati, Ohio, United States, 45219
United States, Oregon
Oregon Dermatology and Research Center
Portland, Oregon, United States, 97210
United States, Rhode Island
Clinical Partners, LLC
Johnston, Rhode Island, United States, 02919
United States, Tennessee
The Skin Wellness Center, PC
Knoxville, Tennessee, United States, 37922
United States, Texas
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, United States, 78229

Sponsors and Collaborators

Stiefel, a GSK Company

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00689481 History of Changes
Other Study ID Numbers:	114742, U0267-302
Study First Received:	May 29, 2008
Results First Received:	November 5, 2010
Last Updated:	October 20, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Plaque-type Psoriasis
psoriasis

Additional relevant MeSH terms:

Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on February 12, 2012