Clinical trial NCT00688519: Study to Compare U0267 Against Vehicle in Subjects With Plaque-type Psoriasis One of Two Phase 3 Studies
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Keywords: Plaque-type Psoriasis
Psoriasis
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2008-06-03
Enrollment: 336
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Number of Subjects With Treatment Success, Assessed Per the Investigator's Static Global Assessment (ISGA)
timeFrame: 8 weeks
Secondary outcomes:
measure: 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
timeFrame: 8 weeks
measure: 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
timeFrame: 8 weeks
measure: Number of Subjects With a Target Lesion Score of 0 for Plaque Thickness at Week 8
timeFrame: 8 weeks
measure: Number of Subjects Who Have an ISGA Score of 0 or 1 at Week 8
timeFrame: 8 weeks
measure: Number of Subjects Who Have Treatment Success at Week 8 Analyzed by Baseline ISGA (Mild or Moderate)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Therapeutics Clinical Research Center, Inc.
state: California
city: Denver
country: United States
facility: Cherry Creek Research, Inc.
state: Colorado
city: Miami
country: United States
facility: Florida Academic Dermatology Centers
state: Florida
city: Miami
country: United States
facility: FXM Research
state: Florida
city: Louisville
country: United States
facility: DermResearch, PLLC
state: Kentucky
city: Boston
country: United States
facility: Massachusetts General Hospital Clinical Unit for Research Trials in Skin
state: Massachusetts
city: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: New York
country: United States
facility: Mount Sinai School of Medicine, Department of Dermatology
state: New York
city: High Point
country: United States
facility: Dermatology Consulting Services
state: North Carolina
city: Portland
country: United States
facility: Oregon Medical Research Center, P.C.
state: Oregon
city: Dallas
country: United States
facility: Dermatology Treatment & Research Center
state: Texas
city: Houston
country: United States
facility: The Center for Skin Research
state: Texas
city: Salt Lake City
country: United States
facility: Dermatology Research Center, Inc.
state: Utah
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.