Psoriasis
Conditions
Keywords
psoriasis, topical therapy
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
Interventions
DRUGQRX-101 75 mcg/g ointment applied QD
DRUGQRX-101 75 mcg/g ointment applied BID
Sponsors
QuatRx Pharmaceuticals Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Percent change from baseline PSS at weeks 2 and 4 | — |
| Ordinal PSS at weeks 2, 4, and 8 | — |
| Dichotomized PGA at weeks 2 and 4 | — |
| Body surface area (BSA) involvement at weeks 2, 4, and 8 | — |
| Individual symptom scores (erythema, induration, and scaling) at weeks 2, 4, and 8 | — |
| Ordinal PGA at weeks 2, 4, and 8 | — |
Countries
United States
Outcome results
None listed