Study to Compare U0267 Against Vehicle in Subjects With Plaque-type Psoriasis One of Two Phase 3 Studies
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
2 other identifiers
interventional
336
1 country
13
Brief Summary
The purpose of the study is to demonstrate the safety and efficacy of U0267 in subjects with plaque-type psoriasis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2008
Shorter than P25 for phase_3
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 29, 2008
CompletedFirst Posted
Study publicly available on registry
June 3, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedResults Posted
Study results publicly available
December 8, 2010
CompletedJanuary 2, 2017
November 1, 2016
9 months
May 29, 2008
November 5, 2010
November 15, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Subjects With Treatment Success, Assessed Per the Investigator's Static Global Assessment (ISGA)
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
Secondary Outcomes (5)
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
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
Number of Subjects With a Target Lesion Score of 0 for Plaque Thickness at Week 8
8 weeks
Number of Subjects Who Have an ISGA Score of 0 or 1 at Week 8
8 weeks
Number of Subjects Who Have Treatment Success at Week 8 Analyzed by Baseline ISGA (Mild or Moderate)
8 weeks
Study Arms (2)
U0267 Foam
EXPERIMENTALU0267 is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
Vehicle foam
PLACEBO COMPARATORVehicle 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.
Interventions
All treatments will be administered topically twice daily (morning and evening) for 8 weeks to areas affected with psoriasis (excluding face and scalp).
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
You may qualify if:
- Male or female subjects at least 12 years old and in good general health.
- Mild to moderate plaque-type psoriasis
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stiefel, a GSK Companylead
- GlaxoSmithKlinecollaborator
Study Sites (13)
Therapeutics Clinical Research Center, Inc.
San Diego, California, 92123, United States
Cherry Creek Research, Inc.
Denver, Colorado, 80209, United States
Florida Academic Dermatology Centers
Miami, Florida, 33136, United States
FXM Research
Miami, Florida, 33175, United States
DermResearch, PLLC
Louisville, Kentucky, 40217, United States
Massachusetts General Hospital Clinical Unit for Research Trials in Skin
Boston, Massachusetts, 02114, United States
Minnesota Clinical Study Center
Fridley, Minnesota, 55432, United States
Mount Sinai School of Medicine, Department of Dermatology
New York, New York, 10029, United States
Dermatology Consulting Services
High Point, North Carolina, 27262, United States
Oregon Medical Research Center, P.C.
Portland, Oregon, 97223, United States
Dermatology Treatment & Research Center
Dallas, Texas, 75230, United States
The Center for Skin Research
Houston, Texas, 77056, United States
Dermatology Research Center, Inc.
Salt Lake City, Utah, 84124, United States
Related Publications (1)
Feldman SR, Matheson R, Bruce S, Grande K, Markowitz O, Kempers S, Brundage T, Wyres M; U0267-301 & 302 Study Investigators. Efficacy and safety of calcipotriene 0.005% foam for the treatment of plaque-type psoriasis: results of two multicenter, randomized, double-blind, vehicle-controlled, phase III clinical trials. Am J Clin Dermatol. 2012 Aug 1;13(4):261-71. doi: 10.2165/11630710-000000000-00000.
PMID: 22587791DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2008
First Posted
June 3, 2008
Study Start
March 1, 2008
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
January 2, 2017
Results First Posted
December 8, 2010
Record last verified: 2016-11
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.