Safety and Efficacy Study of Two Dose Regimens of Becocalcidiol in the Treatment of Plaque-Type Psoriasis
Phase 2
Completed
- Conditions
- Psoriasis
- Registration Number
- NCT00373516
- Lead Sponsor
- QuatRx Pharmaceuticals Company
- 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 topically twice daily for 8 weeks
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Dichotomized Physician's Static Global Assessment of Overall Lesion Severity (PGA)at Week 8 Percent Change from Baseline in Psoriasis Symptom Severity (PSS)Scale at Week 8
- Secondary Outcome Measures
Name Time Method Dichotomized PGA at weeks 2 and 4 Ordinal PGA at weeks 2, 4, and 8 Percent change from baseline PSS at weeks 2 and 4 Ordinal PSS at weeks 2, 4, and 8 Individual symptom scores (erythema, induration, and scaling) at weeks 2, 4, and 8 Body surface area (BSA) involvement at weeks 2, 4, and 8
Trial Locations
- Locations (1)
Clinical Research Site
🇺🇸San Antonio, Texas, United States