Psoriasis Clinical Trial
Safety and Efficacy Study of Two Dose Regimens of Becocalcidiol in the Treatment of Plaque-Type Psoriasis
Summary
The purpose of this study is to evaluate the efficacy and safety of two dosing regimens of QRX-101 ointment (75 mcg/g QD and 75mcg/g BID) in the treatment of plaque-type psoriasis when applied topically twice daily for 8 weeks
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of stable plaque-type psoriasis affecting 2% to 10% of the subject's body surface area
Psoriasis of a severity that is appropriate for treatment with topical therapy; PGA of at least 3 (moderate) at baseline; PSS of at least 7, and with no individual symptom score (erythema, induration, or scaling) less than 2
Subject must sign the IRB approved informed consent and agree to follow dosing instructions and complete required clinic visits.
Exclusion Criteria:
Pregnant or nursing females
Systemic corticosteroids, methotrexate, cyclosporine, systemic retinoids, prolonged sun exposure or ultraviolet light therapy within 4 weeks of dosing
Topical corticosteroids, retinoids, calcipotriene, coal tar, anthralin, or any other treatment indicated for psoriasis within 2 weeks of dosing
Untreated bacterial, tubercular, fungal or any viral lesion of the skin
Biologic agents/monoclonal antibodies in the last 6 months
Currently using lithium or plaquenil
Currently using a beta-blocking medication or thiazide diuretic and the dose has not been stabilized for at least 6 months
History of hypercalcemia or evidence of vitamin D toxicity
Current or history of melanoma skin cancer in the past 5 years
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There are 12 Locations for this study
Hot Springs Arkansas, 71913, United States
Santa Rosa California, 95404, United States
Overland Park Kansas, 66215, United States
Lexington Kentucky, 40509, United States
Louisville Kentucky, 40217, United States
Ann Arbor Michigan, 48109, United States
Edina Minnesota, 55435, United States
Winston-Salem North Carolina, 27157, United States
Temple Pennsylvania, 19560, United States
Anderson South Carolina, 29621, United States
Simpsonville South Carolina, 29681, United States
San Antonio Texas, 78229, United States
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