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

Last updated: November 30, 2016
Sponsor: Stiefel, a GSK Company
Overall Status: Completed

Phase

3

Condition

Warts

Rosacea

Rash

Treatment

N/A

Clinical Study ID

NCT01139580
114743
U0267-303
  • Ages > 12
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Capable of understanding and willing to provide signed and dated written voluntaryinformed consent (and any local or national authorization requirements) before anyprotocol-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 ascore of 2 or 3 (0-5 scale) for erythema, scaling and plaque thickness. Lesionson the palms/soles, knees, elbow, and intertriginous areas should not be used asthe 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 activefemales of childbearing potential participating in the study must agree to use amedically acceptable method of contraception while receiving protocol-assignedproduct. A woman of childbearing potential is defined as one who is biologicallycapable of becoming pregnant; including perimenopausal women who are fewer than 2years from their last menses.

Exclusion

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 notwell-controlled.

  • Use of nonbiologic systemic anti-psoriatic therapy (eg, corticosteroids, psoralencombined with exposure to ultraviolet light A [PUVA], ultraviolet light B [UVB],retinoids, methotrexate, cyclosporine, other immunosuppressive agents) within 4 weeksprior to enrollment.

  • Systemic treatment with biological therapies (marketed or not marketed) with apossible effect on psoriasis within 4 weeks (etanercept), 2 months (adalimumab,alefacept, infliximab), 4 months (ustekinumab) or 4 weeks/5 half-lives (whichever islonger) for experimental products prior to randomization.

  • Use of topical therapies that have a known beneficial effect on psoriasis, includingbut not limited to corticosteroids, retinoids, Vitamin D derivatives, coal tar, oranthralin, 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, currentlyparticipating in another clinical trial, or plans to receive an investigationalproduct 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 subjectat unacceptable risk for participation in the study.

  • Employees of the investigator; study center; or Stiefel, a GSK company involved in thestudy; or an immediate family member (eg, partner, offspring, parents, siblings orsibling's offspring) of an employee involved in the study.

Study Design

Total Participants: 363
Study Start date:
May 01, 2010
Estimated Completion Date:
December 31, 2010

Study 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.

Connect with a study center

  • Genova Clinical Research

    Tucson, Arizona 85791
    United States

    Site Not Available

  • Therapeutics Clinical Research Center, Inc.

    San Diego, California 92123
    United States

    Site Not Available

  • Cherry Creek Research, Inc.

    Denver, Colorado 80209
    United States

    Site Not Available

  • Miami Dermatology Research Institute LLC

    North Miami Beach, Florida 33169
    United States

    Site Not Available

  • MedaPhase, Inc.

    Newnan, Georgia 30263
    United States

    Site Not Available

  • Gwinnett Clinical Research Center, Inc.

    Snellville, Georgia 30078
    United States

    Site Not Available

  • DermResearch, PLLC

    Louisville, Kentucky 40217
    United States

    Site Not Available

  • Dermatology Specialists

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Henry Ford Medical Center

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Grekin Skin Institute

    Warren, Michigan 48088
    United States

    Site Not Available

  • Minnesota Clinical Study Center

    Fridley, Minnesota 55432
    United States

    Site Not Available

  • Central Dermatology PC

    St. Louis, Missouri 63117
    United States

    Site Not Available

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

    New York, New York 10029
    United States

    Site Not Available

  • Dermatology Associates of Rochester, PC

    Rochester, New York 14623
    United States

    Site Not Available

  • Dermatology Consulting Services

    High Point, North Carolina 27262
    United States

    Site Not Available

  • Wake Forest University Health Sciences Department of Dermatology

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • Group Health Associates

    Cincinnatti, Ohio 45220
    United States

    Site Not Available

  • Oregon Medical

    Portland, Oregon 97223
    United States

    Site Not Available

  • Coastal Carolina Research Center

    Mt. Pleasant, South Carolina 29464
    United States

    Site Not Available

  • The Skin Wellness Center, PC

    Knoxville, Tennessee 37922
    United States

    Site Not Available

  • Tennessee Clinical Research

    Nashville, Tennessee 37215
    United States

    Site Not Available

  • DermReserach, Inc.

    Austin, Texas 78759
    United States

    Site Not Available

  • Suzanne Bruce and Associates, PA

    Houston, Texas 77056
    United States

    Site Not Available

  • Dermatology Clinical Research Center of San Antonio

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Dermatology Research Center, Inc.

    Salt Lake City, Utah 84124
    United States

    Site Not Available

  • Education and Research Foundation

    Lynchburg, Virginia 24501
    United States

    Site Not Available

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