Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Phase 3 Study of the Safety and Efficacy of Emulsion Formulation U0267, Versus Vehicle in Subjects With Plaque-type Psoriasis
Brief Summary: The purpose of the study is to demonstrate the safety and efficacy of U0267 in subjects with plaque-type psoriasis.


Options:
A: 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
B: Inclusion Criteria:

* 18 years of age or older
* able and willing to provide written informed consent
* diagnosed with chronic plaque psoriasis
* 3% to 15% body surface area involved
* in good general health

Exclusion Criteria:

* other current treatments for psoriasis
* renal or liver dysfunction
* pregnant or nursing
C: Inclusion Criteria:

* Male or female subjects at least 12 years old and in good general health.
* Mild to moderate plaque-type psoriasis

Exclusion Criteria:

* Known allergy or other adverse reaction to calcipotriene or other vitamin D analogs; or to any component of the investigational formulations
* History of hypercalcemia or of vitamin D toxicity.
* Diagnosis of generalized pustular or erythrodermic exfoliative psoriasis.
* Other serious skin disorder or any chronic medical condition that is not well controlled.
* Use of non-biologic systemic anti-psoriatic therapy or biologic therapy within four weeks of enrollment.
* Use of topical therapies that have a known beneficial effect on psoriasis, within 2 weeks of enrollment.
* Systemic medications for other medical conditions that are known to affect psoriasis within the past four weeks of enrollment.
* Use of any investigational therapy within 4 weeks of enrollment.
* Pregnant women, women who are breast feeding, or sexually active women of child bearing potential who are not practicing an acceptable method of birth control.
D: Inclusion Criteria:

* A clinical diagnosis of stable plaque psoriasis for at least 6 months representing a maximum of 10% of BSA with a minimum of 1% BSA excluding the face, groin ,scalp and genital regions and with a minimum of one target plaque that is at least 2 x 2 cm in size at Day 0.
* PGA of 2 to 4 at Day 0.
* In good general health and free of any disease state or physical condition that might impair the evaluation of plaque psoriasis.
* Women of child bearing potential (WOCBP) must have a negative serum beta-human chorionic gonadotrophin (b-hCG) pregnancy test before randomization. WOBCP who are not abstinent from sex with male partners may be entered into the study if they are willing to continue to use adequate contraceptive precautions for the duration of the study. Male patients with female sexual partners who are able to become pregnant must ensure that an acceptable method of birth control is used while they are in the study. Women who are lactating will not be eligible for the study.
* Willing and able to comply with the protocol and likely to attend all study visits.
* Provide written, informed consent prior to the initiation of any study-related procedures.

Exclusion Criteria:

* Spontaneously improving or rapidly deteriorating plaque psoriasis.
* Any other skin diseases that might interfere with the clinical assessment of plaque psoriasis and/or put the patient at risk.
* Pustular, erythrodermic or other non-plaque forms pf psoriasis.
* Guttate psoriasis as the dominant form of psoriasis.
* Other concomitant, serious illness or medical condition (eg., human immunodeficiency virus, renal insufficiency, clinically significant abnormal laboratory values) that could put the patient at risk during the study.
* History of neurological/psychiatric disorders, including psychotic disorders or dementia, or any other reason that would interfere with the patient's participation in the trial.
* Systemic immunomodulatory therapy known to affect psoriasis and decreases immune cell populations (eg., alefacept) within 24 weeks of the baseline visit.
* Systemic immunomodulatory therapy known to affect psoriasis and that does not typically decrease immune cell populations (eg., etanercept) within 12 weeks prior to the baseline visit.
* Any phototherapy (including laser for the treatment of psoriasis), photo-chemotherapy,or systemic psoriasis therapy (such as systemic corticosteroids, methotrexate, retinoids or cyclosporine) within 4 weeks prior to the baseline visit.
* Prolonged exposure to artificial or natural sources of ultraviolet radiation within 4 weeks prior to the baseline visit or intention to have such exposure during the study, thought by the investigator likely to modify the patient's psoriasis.
* Topical anti-psoriatic therapy (including topical retinoids and vitamin D analogs) on the areas to be treated within 2 weeks prior to the baseline visit.
* Alcohol abuse during the last 2 years as defined by the consumption of \>14 standard drinks of alcohol per week.
* Use of lithium within 2 weeks prior to the screening visit.
* Use of beta blockers (eg., propranolol) within 2 weeks prior to the screening visit unless on a stable dose for \>3 months.
* Known or suspected hypersensitivity to any of the constituents of the investigational product.
* Treatment with an investigational drug within 1 month of Day 0 or current participation in another clinical trial.

Answer: C