Phase
Condition
Psoriasis And Psoriatic Disorders
Warts
Scalp Disorders
Treatment
N/AClinical Study ID
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or non-pregnant, non-lactating female subjects aged at least 18 years at Visit 1.
A clinical diagnosis of stable (at least 6 months) psoriasis vulgaris involving 5% to 30% body surface area (BSA), not including the face, axilla and groin.
A PGA of disease severity of at least moderate disease severity (Grade ≥ 3).
A plaque elevation of at least moderate severity (Grade ≥ 3) at the target lesionsite. The most severe lesion at baseline should be identified as the target lesion.
Provide written informed consent. -
Exclusion
Exclusion Criteria:
Current diagnosis of unstable forms of psoriasis in the treatment area includingguttate, erythrodermic, exfoliative, or pustular psoriasis.
Other inflammatory skin disease in the treatment area that may confound the evaluationof the psoriasis vulgaris (e.g., atopic dermatitis, contact dermatitis, tineacorporis).
Presence of pigmentation, extensive scarring, pigmented lesions, or sunburn in thetreatment areas that could interfere with the rating of efficacy parameters.
History of psoriasis unresponsive to topical treatments.
History of hypersensitivity to any component of the Test or Reference product.
Current or past history of hypercalcemia, calcium metabolism disorder, vitamin Dtoxicity, severe renal insufficiency, or severe hepatic disorders.
Current immunosuppression.
Use within 6 months prior to baseline of biologic treatment for psoriasis (e.g.,infliximab, adalimumab, alefacept).
Use within 3 months prior to baseline of: 1) chemotherapy or 2) radiation therapy.
Use within 2 months prior to baseline of: 1) immunosuppressive drugs (e.g.,tacrolimus, pimecrolimus) or 2) oral retinoids.
Use within 1 month prior to baseline of: 1) systemic steroids, 2) systemicantibiotics, 3) other systemic antipsoriatic treatment, 4) psoralen and ultraviolet A (PUVA) therapy, 5) ultraviolet B (UVB) therapy, or 6) systemic anti-inflammatoryagents. Note: a) Non-steroidal anti-inflammatory drugs (NSAIDs) and aspirin use on anas-needed basis and if not used consecutively for > 14 days prior to baseline and/orduring the study is acceptable. Low-dose (81 mg) aspirin taken daily is acceptable. b)Intranasal or inhaled corticosteroids are acceptable if kept constant throughout thestudy. Intra-articular steroid injections are permissible.
Use within 2 weeks prior to baseline of: 1) topical antipsoriatic drugs (e.g.,salicylic acid, anthralin, coal tar, calcipotriene, tazarotene), 2) topicalcorticosteroids, or 3) topical retinoids.
Use within 2 weeks prior to baseline of: 1) vitamin D supplements 2) vitamin D analogsat a dose >400 IU/day; or 3) calcium supplements (including multivitamins containingcalcium).
Started beta-blocker therapy, antimalarial products, and/or lithium within 3 months ofbaseline. Subjects who have been on a steady dose for at least 3 months prior tobaseline and will remain on the same dose throughout the study are eligible for studyparticipation.
Subjects with planned phototherapy and/or exposure to ultraviolet A (UVA) and/or UVBduring the study.
Study Design
Connect with a study center
Investigational Site 20
Encinitas, California 92024
United StatesSite Not Available
Investigational Site 18
Fountain Valley, California 92708
United StatesSite Not Available
Investigational Site 15
San Diego, California 92123
United StatesSite Not Available
Investigational Site 19
San Diego, California 92108
United StatesSite Not Available
Investigational Site 23
San Diego, California 92123
United StatesSite Not Available
Investigational Site 17
Santa Ana, California 92705
United StatesSite Not Available
Investigational Site 22
Santa Monica, California 90404
United StatesSite Not Available
Investigational Site 29
Clearwater, Florida 33761
United StatesSite Not Available
Investigational Site 27
Coral Gables, Florida 33134
United StatesSite Not Available
Investigational Site 1
Miami, Florida 33144
United StatesSite Not Available
Investigational Site 26
Pinellas Park, Florida 33781
United StatesSite Not Available
Investigational Site 9
Savannah, Georgia 31406
United StatesSite Not Available
Investigational Site 10
New Albany, Indiana 47150
United StatesSite Not Available
Investigational Site 3
Overland Park, Kansas 66215
United StatesSite Not Available
Investigational Site 16
Louisville, Kentucky 40241
United StatesSite Not Available
Investigational Site 21
Saint Joseph, Missouri 64506
United StatesSite Not Available
Investigational Site 12
Henderson, Nevada 89052
United StatesSite Not Available
Investigational Site 28
New York, New York 10019
United StatesSite Not Available
Investigational Site 4
High Point, North Carolina 27262
United StatesSite Not Available
Investigational Site 24
Wilmington, North Carolina 28405
United StatesSite Not Available
Investigational Site 8
Beachwood, Ohio 44122
United StatesSite Not Available
Investigational Site 2
Cincinnati, Ohio 45246
United StatesSite Not Available
Investigational Site 13
Greenville, South Carolina 29607
United StatesSite Not Available
Investigational Site 7
Knoxville, Tennessee 37922
United StatesSite Not Available
Investigational site 31
Murfreesboro, Tennessee 37130
United StatesSite Not Available
Investigational Site 25
Nashville, Tennessee 37215
United StatesSite Not Available
Investigational Site 5
Austin, Texas 78759
United StatesSite Not Available
Investigational Site 11
San Antonio, Texas 78213
United StatesSite Not Available
Investigational Site 14
San Antonio, Texas 78249
United StatesSite Not Available
Investigational Site 30
Webster, Texas 77598
United StatesSite Not Available
Investigational Site 6
Norfolk, Virginia 23507
United StatesSite Not Available
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