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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier:
NCT00689481
First received: May 29, 2008
Last updated: April 5, 2012
Last verified: April 2012
  Purpose

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


Condition Intervention Phase
Psoriasis
Drug: U0267 Foam
Drug: Vehicle foam
Phase 3

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:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Subjects With Treatment Success, Assessed Per the Investigator's Static Global Assessment [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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:
  • 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 [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 323
Study Start Date: March 2008
Study Completion Date: December 2008
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

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline ( Stiefel, a GSK Company )
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: April 5, 2012
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 October 19, 2014