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

Completed · Phase 3

Conditions studied: Psoriasis

In brief

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

Key facts

Study ID: NCT01139580
Run by: Stiefel, a GSK Company
People needed: 363
Starts: 2010-05-01
Expected to finish: 2010-12-01
Last updated by the study team: 2017-01-18

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

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

Full record on ClinicalTrials.gov

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