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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: Vehicle (Placebo) applied BID
* Drug: QRX-101 75 mcg/g ointment applied QD
* Drug: QRX-101 75 mcg/g ointment applied BID


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Vehicle (Placebo) applied BID|nan|
|Drug: QRX-101 75 mcg/g ointment applied QD|nan|
|Drug: QRX-101 75 mcg/g ointment applied BID|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psoriasis, topical therapy