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

QuatRx Pharmaceuticals Company1 site in 1 country150 target enrollmentSeptember 2004

ConditionsPsoriasis

DrugsVehicle (Placebo) applied BID QRX-101 75 mcg/g ointment applied QD QRX-101 75 mcg/g ointment applied BID

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Psoriasis
Sponsor: QuatRx Pharmaceuticals Company
Enrollment: 150
Locations: 1
Primary Endpoint: Dichotomized Physician's Static Global Assessment of Overall Lesion Severity (PGA)at Week 8
Status: Completed
Last Updated: 19 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

September 2004

End Date

March 2005

Last Updated

19 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

QuatRx Pharmaceuticals Company

Eligibility Criteria

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

Outcomes

Primary Outcomes

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 Outcomes

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