Plaque Psoriasis. Clinical Trial
Official title:
ASIS for Enbrel in Plaque Psoriasis
AUTOMATIC SUBDERMAL INJECTOR SYSTEM (ASIS) Corporation has developed and patented the only automatic injection system for delivery of injectable products to the optimum spot, just outside of the fascia, which exists subdermally (between the skin and muscle) or interfascial (between the deeper muscles). ASIS device creates that bloodless space, enhancing Enbrel's efficacy and preventing unnecessary distant spread and adverse reactions. This space remains bloodless as long as the skin is lifted up or filled with an injectable product. Although ASIS device was initially designed to best administer BOTOX for such muscular conditions as Upper limb Spasticity, Cervical Dystonia, Chronic Migraine, Strabismus, Blepharospasm, and Primary Axillary Hyperhidrosis, the technology will also benefit other injectable products, including: GAMMAGARD for Primary Immunodeficiency (PI) and Insulin for Diabetics, etc.
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment