Phase
Condition
Warts
Rosacea
Rash
Treatment
N/AClinical Study ID
Ages > 12 All Genders
Study Summary
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
Study Description
Connect with a study center
Genova Clinical Research
Tucson, Arizona 85791
United StatesSite Not Available
Therapeutics Clinical Research Center, Inc.
San Diego, California 92123
United StatesSite Not Available
Cherry Creek Research, Inc.
Denver, Colorado 80209
United StatesSite Not Available
Miami Dermatology Research Institute LLC
North Miami Beach, Florida 33169
United StatesSite Not Available
MedaPhase, Inc.
Newnan, Georgia 30263
United StatesSite Not Available
Gwinnett Clinical Research Center, Inc.
Snellville, Georgia 30078
United StatesSite Not Available
DermResearch, PLLC
Louisville, Kentucky 40217
United StatesSite Not Available
Dermatology Specialists
Louisville, Kentucky 40202
United StatesSite Not Available
Henry Ford Medical Center
Detroit, Michigan 48202
United StatesSite Not Available
Grekin Skin Institute
Warren, Michigan 48088
United StatesSite Not Available
Minnesota Clinical Study Center
Fridley, Minnesota 55432
United StatesSite Not Available
Central Dermatology PC
St. Louis, Missouri 63117
United StatesSite Not Available
Mt. Sinai School of Medicine Div. Dermatologic & Cosmetic Surgery
New York, New York 10029
United StatesSite Not Available
Dermatology Associates of Rochester, PC
Rochester, New York 14623
United StatesSite Not Available
Dermatology Consulting Services
High Point, North Carolina 27262
United StatesSite Not Available
Wake Forest University Health Sciences Department of Dermatology
Winston-Salem, North Carolina 27157
United StatesSite Not Available
Group Health Associates
Cincinnatti, Ohio 45220
United StatesSite Not Available
Oregon Medical
Portland, Oregon 97223
United StatesSite Not Available
Coastal Carolina Research Center
Mt. Pleasant, South Carolina 29464
United StatesSite Not Available
The Skin Wellness Center, PC
Knoxville, Tennessee 37922
United StatesSite Not Available
Tennessee Clinical Research
Nashville, Tennessee 37215
United StatesSite Not Available
DermReserach, Inc.
Austin, Texas 78759
United StatesSite Not Available
Suzanne Bruce and Associates, PA
Houston, Texas 77056
United StatesSite Not Available
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas 78229
United StatesSite Not Available
Dermatology Research Center, Inc.
Salt Lake City, Utah 84124
United StatesSite Not Available
Education and Research Foundation
Lynchburg, Virginia 24501
United StatesSite Not Available

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