Safety and Efficacy Study of Two Dose Regimens of Becocalcidiol in the Treatment of Plaque-Type Psoriasis
Completed · Phase 2 · Has a placebo group
Conditions studied: Psoriasis
In brief
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
Key facts
- Study ID
- NCT00373516
- Run by
- QuatRx Pharmaceuticals Company
- People needed
- 150
- Starts
- 2004-09-01
- Expected to finish
- 2005-03-01
- Last updated by the study team
- 2006-09-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Clinical Research Site — Hot Springs, Arkansas, United States
- Clinical Research Site — Santa Rosa, California, United States
- Clinical Research Site — Overland Park, Kansas, United States
- Clinical Research Site — Lexington, Kentucky, United States
- Clinical Research Site — Louisville, Kentucky, United States
- Clinical Research Site — Ann Arbor, Michigan, United States
- Clinical Research Site — Edina, Minnesota, United States
- Clinical Research Site — Winston-Salem, North Carolina, United States
- Clinical Research Site — Temple, Pennsylvania, United States
- Clinical Research Site — Anderson, South Carolina, United States
- Clinical Research Site — Simpsonville, South Carolina, United States
- Clinical Research Site — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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