Clinical trial NCT00689481: Study to Compare U0267 Against Vehicle in Subjects With Plaque-type Psoriasis Two 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 Foam 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: 323
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
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: Mobile
country: United States
facility: Coastal Clinical Research, Inc.
state: Alabama
city: Fremont
country: United States
facility: Center for Dermatology Cosmetic and Laser Surgery
state: California
city: Ormond Beach
country: United States
facility: Advanced Dermatology & Cosmetic Surgery
state: Florida
city: Overland Park
country: United States
facility: Adult & Pediatric Dermatology
state: Kansas
city: Albuquerque
country: United States
facility: Academic Dermatology Associates
state: New Mexico
city: Rochester
country: United States
facility: The Center for Dermatology at Lifetime Health
state: New York
city: Winston Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Cincinnati
country: United States
facility: University Dermatology Consultants, Inc.
state: Ohio
city: Portland
country: United States
facility: Oregon Dermatology and Research Center
state: Oregon
city: Johnston
country: United States
facility: Clinical Partners, LLC
state: Rhode Island
city: Knoxville
country: United States
facility: The Skin Wellness Center, PC
state: Tennessee
city: San Antonio
country: United States
facility: Dermatology Clinical Research Center of San Antonio
state: Texas
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.