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

NCT01139580 | Completed Phase 3 Results

• 2 other identifiers: 114743U0267-303
• Study Type: interventional
• Target: 363
• Locations: 1 country
• Sites: 26

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.

Conditions

Psoriasis

Keywords

Plaque Psoriasis; Psoriasis

Outcome Measures

Primary Outcomes (2)

• Number of Participants With an Investigator's Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) for Scalp Involvement at Week 8 Using the Failure Method

  The investigator assessed participants with scalp psoriasis using the ISGA, scored as (as a visual average of lesions): 0, absence of disease; 1, very mild disease, lesions (L) with minimum erythema; 2, mild disease, L with light-red coloration, slight thickness, and fine, thin scale layer; 3, moderate disease, L with red coloration, moderate thickness, and a moderate scaled layer; 4, severe disease, L with red coloration, severe thickness, and a severe coarse, thick scale layer; 5, very severe disease, L with red coloration, very severe thickness, and a very severe, coarse, thick scale layer.

  Week 8

• Number of Participants With an ISGA Score of Clear (0) or Almost Clear (1) for Scalp Involvement at Week 8 Using Last Observation Carried Forward (LOCF)

  The investigator assessed participants with scalp psoriasis using the ISGA, scored as (as a visual average of lesions): 0, absence of disease; 1, very mild disease, lesions (L) with minimum erythema; 2, mild disease, L with light-red coloration, slight thickness, and fine, thin scale layer; 3, moderate disease, L with red coloration, moderate thickness, and a moderate scaled layer; 4, severe disease, L with red coloration, severe thickness, and a severe coarse, thick scale layer; 5, very severe disease, L with red coloration, very severe thickness, and a very severe, coarse, thick scale layer.

  Week 8

Secondary Outcomes (4)

• Number of Participants With a Target Lesion Score of 0 or 1 for Erythema and at Least a 2 Grade Improvement From Baseline at Week 8

  Baseline and Week 8

• Number of Participants With a Target Lesion Score of 0 or 1 for Scaling and at Least a 2 Grade Improvement From Baseline at Week 8

  Baseline and Week 8

• Number of Participants With a Target Lesion Score of 0 or 1 for Plaque Thickness at Week 8

  Baseline and Week 8

• Number of Participants With an ISGA Score of Clear (0) or Almost Clear (1) for Body Involvement at Week 8

  Week 8

Study Arms (2)

Calcipotriene Foam

EXPERIMENTAL

Calcipotriene Foam 0.005%,

Drug: Calcipotriene Foam

Vehicle Foam

PLACEBO COMPARATOR

Vehicle Foam

Drug: Vehicle Foam

Interventions

Calcipotriene Foam 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

Calcipotriene Foam

Vehicle Foam DRUG

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

Vehicle Foam

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stiefel, a GSK Company: lead
• GlaxoSmithKline: collaborator

Study Sites (26)

Genova Clinical Research

Tucson, Arizona, 85791, United States

Location

Therapeutics Clinical Research Center, Inc.

San Diego, California, 92123, United States

Location

Cherry Creek Research, Inc.

Denver, Colorado, 80209, United States

Location

Miami Dermatology Research Institute LLC

North Miami Beach, Florida, 33169, United States

Location

MedaPhase, Inc.

Newnan, Georgia, 30263, United States

Location

Gwinnett Clinical Research Center, Inc.

Snellville, Georgia, 30078, United States

Location

Dermatology Specialists

Louisville, Kentucky, 40202, United States

Location

DermResearch, PLLC

Louisville, Kentucky, 40217, United States

Location

Henry Ford Medical Center

Detroit, Michigan, 48202, United States

Location

Grekin Skin Institute

Warren, Michigan, 48088, United States

Location

Minnesota Clinical Study Center

Fridley, Minnesota, 55432, United States

Location

Central Dermatology PC

St Louis, Missouri, 63117, United States

Location

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

New York, New York, 10029, United States

Location

Dermatology Associates of Rochester, PC

Rochester, New York, 14623, United States

Location

Dermatology Consulting Services

High Point, North Carolina, 27262, United States

Location

Wake Forest University Health Sciences Department of Dermatology

Winston-Salem, North Carolina, 27157, United States

Location

Group Health Associates

Cincinnatti, Ohio, 45220, United States

Location

Oregon Medical

Portland, Oregon, 97223, United States

Location

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, 29464, United States

Location

The Skin Wellness Center, PC

Knoxville, Tennessee, 37922, United States

Location

Tennessee Clinical Research

Nashville, Tennessee, 37215, United States

Location

DermReserach, Inc.

Austin, Texas, 78759, United States

Location

Suzanne Bruce and Associates, PA

Houston, Texas, 77056, United States

Location

Dermatology Clinical Research Center of San Antonio

San Antonio, Texas, 78229, United States

Location

Dermatology Research Center, Inc.

Salt Lake City, Utah, 84124, United States

Location

Education and Research Foundation

Lynchburg, Virginia, 24501, United States

Location

Related Links

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

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2010
• First Posted: June 8, 2010
• Study Start: May 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: January 18, 2017
• Results First Posted: September 23, 2011

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will share

Locations

US (26)