Status:
COMPLETED
Safety and Efficacy Study of Two Dose Regimens of Becocalcidiol in the Treatment of Plaque-Type Psoriasis
Lead Sponsor:
QuatRx Pharmaceuticals Company
Conditions:
Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 topical...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
End Date :
March 1 2005
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00373516
Start Date
September 1 2004
End Date
March 1 2005
Last Update
September 8 2006
Active Locations (12)
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1
Clinical Research Site
Hot Springs, Arkansas, United States, 71913
2
Clinical Research Site
Santa Rosa, California, United States, 95404
3
Clinical Research Site
Overland Park, Kansas, United States, 66215
4
Clinical Research Site
Lexington, Kentucky, United States, 40509