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

NCT ID: NCT00689481

Last Updated: 2016-10-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 323 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2008-10-31

Brief Summary

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

Conditions

Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

U0267 Foam

Intervention Type: DRUG

All treatments will be administered topically twice daily (morning and evening) for 8 weeks to areas affected with psoriasis (excluding face and scalp).

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.

Group Type: PLACEBO_COMPARATOR

Vehicle foam

Intervention Type: DRUG

All treatments will be administered topically twice daily (morning and evening) for 8 weeks to areas affected with psoriasis (excluding face and scalp).

Interventions

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).

Intervention Type: 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).

Intervention Type: DRUG

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.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

Stiefel, a GSK Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

Coastal Clinical Research, Inc.

Mobile, Alabama, United States

Center for Dermatology Cosmetic and Laser Surgery

Fremont, California, United States

Advanced Dermatology & Cosmetic Surgery

Ormond Beach, Florida, United States

Adult & Pediatric Dermatology

Overland Park, Kansas, United States

Academic Dermatology Associates

Albuquerque, New Mexico, United States

The Center for Dermatology at Lifetime Health

Rochester, New York, United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

University Dermatology Consultants, Inc.

Cincinnati, Ohio, United States

Oregon Dermatology and Research Center

Portland, Oregon, United States

Clinical Partners, LLC

Johnston, Rhode Island, United States

The Skin Wellness Center, PC

Knoxville, Tennessee, United States

Dermatology Clinical Research Center of San Antonio

San Antonio, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 22587791 (View on PubMed)

Study Documents

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

U0267-302

Identifier Type: OTHER

Identifier Source: secondary_id

114742

Identifier Type: -

Identifier Source: org_study_id