ASIS for Enbrel in Plaque Psoriasis (ASISinPP)

NCT02112097 Phase 1/Phase 2 UNKNOWN

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.

Details

Lead sponsor	ASIS Corporation
Phase	Phase 1/Phase 2
Status	UNKNOWN
Enrolment	60
Start date	2016-01
Completion	2017-06

Conditions

• Plaque Psoriasis.

Interventions

• Gadolinium
• Gadolinium
• Gadolinium
• Efficacy of Enbrel subcutaneously at Week 12
• Efficacy of Enbrel subcutaneously at Week 24
• Efficacy of Enbrel subcutaneously at Week 36
• Efficacy of Enbrel subdermally at Week 12
• Efficacy of Enbrel subdermally at Week 24
• Efficacy of Enbrel subdermally at Week 36
• PASI 75 n(%) subcutaneously at Week 12

Primary outcomes

• Relative Prolongation Ability Score for Gadolinium subdermally injected. — 6 months
  Gadolinium will be injected with ASIS subdermally (30) or conventional subcutaneous (30) for 60 adult subjects with Plaque Psoriasis (involving at least 10% of body surface and a minimum Psoriasis Area \& Severity Index (PASI) score of 10), just for the particular plaque skin area. The first MRI taken promptly after Gadolinium injection for each patient would be his or her reference of 100% Persistent, to which his or her subsequent MRI taken @ 6 hr, @ 12 hr, and @24hr later will be compared for Persistent %.This approximation can only work if the variables are minimized to the same population with Plaque Psoriasis, and the particular plaque skin area. The Relative Prolongation Ability Score or total Persistent % subdermally over total Persistent % subcutaneously, Plaque Psoriasis will be very valuable indicators for us to modify the Enbrel dosage and duration for testing with that "unknown" subdermal bloodless space in Aim 2.

Countries

United States