Study to Compare U0267 Against Vehicle in Subjects With Plaque-type Psoriasis - Full Text View

Sponsor:	Stiefel, a GSK Company
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00688519

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 Psoriasis	Drug: U0267 Drug: Vehicle	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 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's Static Global Assessment) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Number of subjects who have a ISGA score of 0 or 1 at week
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:	343
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 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 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: NCT00688519

Locations

United States, California
Therapeutics Clinical Research Center, Inc.
San Diego, California, United States, 92123
United States, Colorado
Cherry Creek Research, Inc.
Denver, Colorado, United States, 80209
United States, Florida
Florida Academic Dermatology Centers
Miami, Florida, United States, 33136
FXM Research
Miami, Florida, United States, 33175
United States, Kentucky
DermResearch, PLLC
Louisville, Kentucky, United States, 40217
United States, Massachusetts
Massachusetts General Hospital Clinical Unit for Research Trials in Skin
Boston, Massachusetts, United States, 02114
United States, Minnesota
Minnesota Clinical Study Center
Fridley, Minnesota, United States, 55432
United States, New York
Mount Sinai School of Medicine, Department of Dermatology
New York, New York, United States, 10029
United States, North Carolina
Dermatology Consulting Services
High Point, North Carolina, United States, 27262
United States, Oregon
Oregon Medical Research Center, P.C.
Portland, Oregon, United States, 97223
United States, Texas
Dermatology Treatment & Research Center
Dallas, Texas, United States, 75230
The Center for Skin Research
Houston, Texas, United States, 77056
United States, Utah
Dermatology Research Center, Inc.
Salt Lake City, Utah, United States, 84124

Sponsors and Collaborators

Stiefel, a GSK Company

Investigators

Study Director:

David A Angulo, MD

Stiefel, a GSK Company

More Information

No publications provided

Responsible Party:	Jason Mann, Director, Global Clinical Operations, Stiefel Laboratories
ClinicalTrials.gov Identifier:	NCT00688519 History of Changes
Other Study ID Numbers:	114741, U0267-301
Study First Received:	May 29, 2008
Results First Received:	November 5, 2010
Last Updated:	November 5, 2010
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 09, 2012