Clinical trial NCT02112097: ASIS for Enbrel in Plaque Psoriasis
Official title: ASIS for Enbrel in Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Plaque Psoriasis.
Keywords: Plaque Psoriasis.
Subdermal bloodless space
Subdermal injection
Subcutaneous injection
Injectable electromyography needle
Electrical stimulation
MRI with Gadolinium
Lead sponsor: ASIS Corporation
Sponsor class: INDUSTRY
First posted: 2014-04-11
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Relative Prolongation Ability Score for Gadolinium subdermally injected.
timeFrame: 6 months
Secondary outcomes:
measure: Efficacy of Enbrel subcutaneously vs. subdermally in Plaque Psoriasis.
timeFrame: 12 months
Other outcomes:
measure: Adverse Reactions of Enbrel subcutaneously vs. subdermally in Plaque Psoriasis
timeFrame: 12 months
Locations:
city: Westminster
country: United States
facility: Automatic Subdermal Injector System, Inc
state: California
city: Westminster
country: United States
facility: Automatic Subdermal Injector System, Inc
state: California
Study officials:
affiliation: AUTOMATIC SUBDERMAL INJECTOR SYSTEM INC
name: Li Nguyen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AUTOMATIC SUBDERMAL INJECTOR SYSTEM, INC
name: Thanh Phung,, MD
role: PRINCIPAL_INVESTIGATOR
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