Safety and Efficacy Study of Two Dose Regimens of Becocalcidiol in the Treatment of Plaque-Type Psoriasis

A Multi-Center, Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled, Study of the Safety and Efficacy of Two Dosing Regimens of QRX-101 (Becocalcidiol) Ointment in the Treatment of Plaque-Type Psoriasis

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

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