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

QuatRx Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Psoriasis

Treatments

Drug: Vehicle (Placebo) applied BID

Drug: QRX-101 75 mcg/g ointment applied BID

Drug: QRX-101 75 mcg/g ointment applied QD

Study type

Interventional

Funder types

Industry

Identifiers

NCT00373516

QRX-101-CLIN-003

Details and patient eligibility

About

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

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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