Clinical trial NCT01139580: The Purpose of This Study is to Demonstrate the Safety and Effectiveness of Calcipotriene Foam in Subjects With Scalp and Body Psoriasis
Official title: A Multicenter, Randomized, Double-Blind Study of the Safety and Efficacy of Calcipotriene Foam, 0.005%, Versus Vehicle Foam In The Treatment Of Moderate Plaque-Type Scalp And Body Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Keywords: Plaque Psoriasis
Psoriasis
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2010-06-08
Enrollment: 363
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 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.

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.

Primary outcomes:
measure: 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
timeFrame: Week 8
measure: 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)
timeFrame: Week 8
Secondary outcomes:
measure: 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
timeFrame: Baseline and Week 8
measure: 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
timeFrame: Baseline and Week 8
measure: Number of Participants With a Target Lesion Score of 0 or 1 for Plaque Thickness at Week 8
timeFrame: Baseline and Week 8
measure: Number of Participants With an ISGA Score of Clear (0) or Almost Clear (1) for Body Involvement at Week 8
timeFrame: Week 8
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Genova Clinical Research
state: Arizona
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: North Miami Beach
country: United States
facility: Miami Dermatology Research Institute LLC
state: Florida
city: Newnan
country: United States
facility: MedaPhase, Inc.
state: Georgia
city: Snellville
country: United States
facility: Gwinnett Clinical Research Center, Inc.
state: Georgia
city: Louisville
country: United States
facility: Dermatology Specialists
state: Kentucky
city: Louisville
country: United States
facility: DermResearch, PLLC
state: Kentucky
city: Detroit
country: United States
facility: Henry Ford Medical Center
state: Michigan
city: Warren
country: United States
facility: Grekin Skin Institute
state: Michigan
city: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: St. Louis
country: United States
facility: Central Dermatology PC
state: Missouri
city: New York
country: United States
facility: Mt. Sinai School of Medicine Div. Dermatologic & Cosmetic Surgery
state: New York
city: Rochester
country: United States
facility: Dermatology Associates of Rochester, PC
state: New York
city: High Point
country: United States
facility: Dermatology Consulting Services
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences Department of Dermatology
state: North Carolina
city: Cincinnatti
country: United States
facility: Group Health Associates
state: Ohio
city: Portland
country: United States
facility: Oregon Medical
state: Oregon
city: Mt. Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Knoxville
country: United States
facility: The Skin Wellness Center, PC
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Clinical Research
state: Tennessee
city: Austin
country: United States
facility: DermReserach, Inc.
state: Texas
city: Houston
country: United States
facility: Suzanne Bruce and Associates, PA
state: Texas
city: San Antonio
country: United States
facility: Dermatology Clinical Research Center of San Antonio
state: Texas
city: Salt Lake City
country: United States
facility: Dermatology Research Center, Inc.
state: Utah
city: Lynchburg
country: United States
facility: Education and Research Foundation
state: Virginia
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: