The Purpose of This Study is to Demonstrate the Safety and Effectiveness of Calcipotriene Foam in Subjects With Scalp and Body Psoriasis

NCT ID: NCT01139580

Last Updated: 2017-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 363 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2010-12-31

Brief Summary

The purpose of this study is to determine the safety and effectiveness in the treatment of psoriasis on the scalp and on the body.

Detailed Description

The study subjects must have moderate psoriasis of the body and scalp with an ISGA of 3 at baseline. In addition, the subjects must have an evaluable target lesion of at least 2 cm² on the body with a score of 2 or 3 for erythema, scaling and plaque. All subjects will apply Calcipotriene Foam, 0.005% or vehicle foam topically twice a day (am and pm) to all psoriatic lesions on the body and scalp. Study visits will occur at baseline (day 1) and at weeks 1, 2, 4, and 8.

Conditions

Psoriasis

Study Design

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

Study Groups

Calcipotriene Foam

Calcipotriene Foam 0.005%,

Group Type: EXPERIMENTAL

Calcipotriene Foam

Intervention Type: DRUG

Calcipotriene Foam 0.005%. All treatments will be administered to the skin twice daily (am-pm) for 8 weeks for subjects in this group

Vehicle Foam

Vehicle Foam

Group Type: PLACEBO_COMPARATOR

Vehicle Foam

Intervention Type: DRUG

Vehicle Foam. All treatments will be administered to the skin twice daily (am-pm) for 8 weeks for subjects in this group

Interventions

Calcipotriene Foam

Calcipotriene Foam 0.005%. All treatments will be administered to the skin twice daily (am-pm) for 8 weeks for subjects in this group

Intervention Type: DRUG

Vehicle Foam

Vehicle Foam. All treatments will be administered to the skin twice daily (am-pm) for 8 weeks for subjects in this group

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Capable of understanding and willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol-specific procedures are performed.
• Male or female subjects at least 12 years old and in good general health.
• Able to complete the study and to comply with study instructions.
• Moderate plaque-type psoriasis on the body (excluding the scalp and face) defined as:

• Plaque-type psoriasis involving 3% to 10% of total body surface area (BSA).
• An Investigator's Static Global Assessment (ISGA) score of 3 at Baseline.
• Identification of a target lesion (>2 cm²) on the trunk or extremities with a score of 2 or 3 (0-5 scale) for erythema, scaling and plaque thickness. Lesions on the palms/soles, knees, elbow, and intertriginous areas should not be used as the target lesion site.
• Involvement of at least 10% of the total scalp surface area with clinical signs (erythema, thickness, and scaliness) rated as moderate (3) based on the ISGA.
• Negative urine pregnancy test for females of childbearing potential. • Sexually active females of childbearing potential participating in the study must agree to use a medically acceptable method of contraception while receiving protocol-assigned product. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant; including perimenopausal women who are fewer than 2 years from their last menses.

Exclusion Criteria

• Any subject who has participated in any previous calcipotriene foam clinical.
• Female who is pregnant, trying to become pregnant, or breastfeeding.
• 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.
• Other serious skin disorder or any chronic medical condition that is not well-controlled.
• Use of nonbiologic systemic anti-psoriatic therapy (eg, corticosteroids, psoralen combined with exposure to ultraviolet light A [PUVA], ultraviolet light B [UVB], retinoids, methotrexate, cyclosporine, other immunosuppressive agents) within 4 weeks prior to enrollment.
• Systemic treatment with biological therapies (marketed or not marketed) with a possible effect on psoriasis within 4 weeks (etanercept), 2 months (adalimumab, alefacept, infliximab), 4 months (ustekinumab) or 4 weeks/5 half-lives (whichever is longer) for experimental products prior to randomization.
• Use of topical therapies that have a known beneficial effect on psoriasis, including but not limited to corticosteroids, retinoids, Vitamin D derivatives, coal tar, or anthralin, within 2 weeks prior to enrollment.
• Systemic medications for other medical conditions that are known to affect psoriasis (eg, lithium, beta adrenergic blockers) within 4 weeks prior to enrollment.
• Use of any investigational product within 4 weeks prior to enrollment, currently participating in another clinical trial, or plans to receive an investigational product during the study.
• Current drug or alcohol abuse (drug screening not required).
• Has a history of any immuno-compromizing disease.
• Any other condition that, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study.
• Employees of the investigator; study center; or Stiefel, a GSK company involved in the study; or an immediate family member (eg, partner, offspring, parents, siblings or sibling's offspring) of an employee involved in the study.

• 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

Genova Clinical Research

Tucson, Arizona, United States

Therapeutics Clinical Research Center, Inc.

San Diego, California, United States

Cherry Creek Research, Inc.

Denver, Colorado, United States

Miami Dermatology Research Institute LLC

North Miami Beach, Florida, United States

MedaPhase, Inc.

Newnan, Georgia, United States

Gwinnett Clinical Research Center, Inc.

Snellville, Georgia, United States

Dermatology Specialists

Louisville, Kentucky, United States

DermResearch, PLLC

Louisville, Kentucky, United States

Henry Ford Medical Center

Detroit, Michigan, United States

Grekin Skin Institute

Warren, Michigan, United States

Minnesota Clinical Study Center

Fridley, Minnesota, United States

Central Dermatology PC

St Louis, Missouri, United States

Mt. Sinai School of Medicine Div. Dermatologic & Cosmetic Surgery

New York, New York, United States

Dermatology Associates of Rochester, PC

Rochester, New York, United States

Dermatology Consulting Services

High Point, North Carolina, United States

Wake Forest University Health Sciences Department of Dermatology

Winston-Salem, North Carolina, United States

Group Health Associates

Cincinnatti, Ohio, United States

Oregon Medical

Portland, Oregon, United States

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, United States

The Skin Wellness Center, PC

Knoxville, Tennessee, United States

Tennessee Clinical Research

Nashville, Tennessee, United States

DermReserach, Inc.

Austin, Texas, United States

Suzanne Bruce and Associates, PA

Houston, Texas, United States

Dermatology Clinical Research Center of San Antonio

San Antonio, Texas, United States

Dermatology Research Center, Inc.

Salt Lake City, Utah, United States

Education and Research Foundation

Lynchburg, Virginia, United States

Countries

United States

Study Documents

Document Type: Dataset Specification

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: Statistical Analysis Plan

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: Study Protocol

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

View Document

Document Type: Annotated Case Report 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

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

U0267-303

Identifier Type: OTHER

Identifier Source: secondary_id

114743

Identifier Type: -

Identifier Source: org_study_id