ASIS for Enbrel in Plaque Psoriasis

Over 6 months, Aim 1 will demonstrate that ASIS device consistently delivers an injectable
product (e.g. Gadolinium) into that subdermal bloodless space. MRI is the most simple and
logical imaging choice, preferred because with ultrasound, air is injected, which will
dissipate too quickly out of bloodless space to allow measurements. Since there isn't a way
to measure the level of Gadolinium within that subdermal bloodless space, at least the
Prolongation of Gadolinium may be approximated by its greater or longer Persistent % on MRI.
Also, since we can't assume that bloodless space for patients with a particular disease will
behave the same way as normal patients or patients with different diseases, this
approximation only works if the variables are minimized to the same particular skin affected
by Plaque Psoriasis. Case in point, patients with Plaque Psoriasis tend to have thicker
skin, so expectantly will have prolonged Gadolinium subcutaneously Persistent %, which may
be very different from the other diseases and certainly from the skin of normal patients,
while the Gadolinium subdermally Persistent % should remain the same. Therefore, the
Relative Prolongation Ability Score or total Persistent % subdermally over total Persistent
% subcutaneously, will be different and very specific for the particular skin affected by
Plaque Psoriasis. However, they are valuable indicators that will help us modify the Enbrel
dosage and duration to inject into that "unknown" subdermal space for Aim 2, from the
"known" typical Enbrel dosage and duration for Plaque Psoriasis patients. For example, if
Aim 1 found the Relative Prolongation Ability Score for the Plaque Psoriasis skin to be
(2.00), then the typical subcutaneously Enbrel 50mg every 3 days, should be 25mg every 6
days subdermally.

Over 12 months, Aim 2 will again demonstrate the advantages of ASIS device injecting
subdermally versus subcutaneously, but using Enbrel instead of Gadolinium on the particular
skin affected by Plaque Psoriasis. Once we have shown ASIS device's consistent performance
in Aim 1, then we may assume will deliver another product (Enbrel) into that bloodless space
without the need to measure Enbrel's existent in that bloodless space. Using Enbrel instead
of Gadolinium, we'll demonstrate the advantages of injecting subdermally over
intramuscularly for the same affected skin sites in the same 60 adult subjects.

Inclusion Criteria:

- Inclusion Criteria in general and for Gadolinium:

- Main Criteria for Inclusion: Eligible Ages: 12 Years to 65

- Genders Eligible for Study: Both

- Accepts Healthy Volunteers: Yes

- Must be outpatient, male or female, of any race, between 18 and 65 years of age.

- Must be able to understand the requirements of the study including maintaining a
diary, and sign informed consent.

- Must be in good general health as determined by investigator.

- If female of childbearing potential, must have negative pregnancy test result at
screening visit and practice reliable method of contraception

- Inclusion Criteria for Plaque Psoriasis in particular:

- Must have chronic moderate to severe plaque psoriasis and be candidates for systemic
therapy or phototherapy.

- Must have psoriasis involving at least 10% of body surface and a minimum PASI score
of 10.

- Patients are limited to low-moderate-strength topical corticosteroids in axillary,
groin, and scalp regions.

Exclusion Criteria:

- Exclusion Criteria for Plaque Psoriasis in particular:

- Patients with guttate, erythrodermic, or pustular psoriasis and patients with severe
infections within 4 weeks of screening are excluded from study.

- No concomitant major anti-psoriatic therapies are allowed during the study.

- Has chronic or recurrent infection, has been exposed to tuberculosis, has resided or
traveled in areas of endemic tuberculosis or endemic mycoses, such as histoplasmosis,
coccidioidomycosis, or blastomycosis; or has underlying conditions that may
predispose them to infection such as advanced or poorly controlled diabetes